Summary:  

We are seeking an accomplished Staff Regulatory Affairs Specialist to serve as a senior individual contributor and subject matter expert within our growing Regulatory Affairs organization. This is a strategic, high-visibility role for a seasoned regulatory professional who can independently drive complex U.S. and international submissions, shape regulatory strategy across the product portfolio, and mentor junior team members. The ideal candidate brings deep FDA expertise, advanced command of global regulatory landscapes, and a proactive, collaborative mindset to navigating complex, evolving regulatory environments. As a senior member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market. 

In This Role, You Will: 

• Lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings (including 510(k)s, Q-Subs/Pre-Submissions, Special 510(k)s, and Letters to File), ensuring timely approvals and serving as the technical lead on the most challenging submissions. 

• Drive the development and continuous improvement of scalable regulatory infrastructure—including processes, systems, SOPs, and team capabilities—to support organizational growth and evolving compliance needs. 

• Act as a primary liaison with FDA and global regulatory bodies, leading audits, inspections, and key communications, and representing Calyxo with confidence and technical authority. 

• Provide expert regulatory input into product development and design enhancements—including biocompatibility, sterilization, packaging, shelf life, clinical strategy, product roadmaps, and labeling decisions—to ensure compliance is built into the development process. Lead regulatory support for Operations and cost-reduction projects. 

• Oversee regulatory review and approval of promotional materials, advertising claims, and customer-facing communications, owning the claims matrix and serving as final regulatory reviewer. 

• Partner with Quality to ensure our QMS meets global regulatory expectations and supports continuous improvement. Ensure compliance with FDA and other applicable regulations and regulating bodies, including FDA QMSR transition activities. 

• Monitor and interpret proposed regulatory changes from the FDA and other agencies, including worldwide regulatory authorities, and translate them into actionable guidance for the business. 

• Maintain visibility into evolving global regulatory requirements and proactively update internal stakeholders. Develop and manage domestic and international registration and listing activities. 

• Lead risk management, health hazard evaluations, and decision-making processes for field actions, recalls, or advisory notices. 

• Drive regulatory compliance activities such as CAPAs, NCMRs, complaints, and MDR/eMDR processes; serve as a senior reviewer and approver where required. 

• Mentor and develop junior Regulatory Affairs staff, providing technical guidance, review of deliverables, and coaching on regulatory strategy and submission excellence. 

• Champion a culture of regulatory excellence, knowledge sharing, and continuous improvement across the Regulatory Affairs function. 

• Maintain current knowledge and expertise of the regulatory landscape in order to provide expert input and guidance to the business, and serve as the in-house subject matter expert on FDA medical device regulations and selected international jurisdictions. 

Who You Will Report To: 

•  Director, Regulatory Affairs

Requirements: 

• 12+ years' experience in regulatory affairs in medical device, biotechnology, or in-vitro diagnostics (IVD) industry, including substantial experience with Class II or Class III electromechanical medical devices. 

• Extensive prior experience interfacing with the FDA and/or other regulatory agencies is required. Proven success independently leading multiple FDA submissions, including 510(k)s, Special 510(k)s, Q-Subs, and/or PMAs, and driving regulatory strategy through full product development lifecycles. 

• Recognized subject matter expertise in providing regulatory guidance for biocompatibility, packaging, sterilization, software (IEC 62304), electrical safety and EMC (IEC 60601), labeling, and reviewing and approving product claims and promotional content in a fast-paced, innovative environment. 

• Advanced understanding of U.S. regulatory requirements; working knowledge of EU MDR and other international regulations required. U.S. and European/International regulations and standards knowledge is required. 

• Demonstrated ability to lead and influence cross-functional teams, with excellent technical writing skills and a strong record of authoring high-quality regulatory submissions and Letters to File. 

• Strong analytical capabilities, deep understanding of design controls, manufacturing, change control, and awareness of regulatory industry trends. Experience with medical device eQMS is required. 

• Proven mentor and coach — able to develop junior regulatory talent and elevate team capability through knowledge sharing and structured review. 

• Effective communicator and relationship-builder with cross-functional stakeholders, executive leadership, and external regulators. 

• Bachelor's degree in Life Sciences, Engineering, or related field required; advanced degree and/or RAC certification strongly preferred. 

• Travel: 5% travel may be required 

• Location: Pleasanton office (minimum 3-days a week onsite) 

• Must be able to sit for up to 8 hours/day 

• Compliance with relevant county, state, and Federal rules regarding vaccinations. 

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

We also offer an attractive compensation package, which includes: 

• A competitive base salary $160,000 - $175,000 and variable incentive plan  

• Stock options – ownership and a stake in growing a mission-driven company 

• Employee benefits package that includes 401(k), healthcare insurance and paid vacation 

Summary:

The Procedural Excellence Manager position is the internal subject matter expert for how to effectively use Calyxo’s products – including the CVAC System -- to enable its mission to revolutionize kidney stone care.  This role is responsible for developing and maintaining procedural best practices for both commercial and new products, creating customer-facing training materials (including technical documentation), and developing hands-on demonstrations that clarify product value propositions. The Procedural Excellence Manager partners across the organization to synthesize and align diverse perspectives to ensure consistent and compelling communication of product value across all channels. 

In This Role, You Will:

 Develop and Maintain Procedural Best Practices

• Serve as the internal subject matter expert on procedural best practices and provide expertise to functional partners across the organization, as needed.
• Synthesize personal case experience with feedback from surgeons, sales, clinical specialists, field trainers, product managers, and clinical development engineers to identify and prioritize new procedural education needs.
• Define and maintain standardized procedural narratives, techniques, and “reasons to believe” that clearly articulate product value and differentiation versus competitive technologies.
• Act as a key resource for the sales team, providing procedural insights on the CVAC System (including ancillaries) and competitive technologies.

 Create Customer‑ and Field-Facing Training Materials & Technical Documentation

• Own the strategy, development, and continuous improvement of procedural training content, including videos, animations, presentations, digital modules, and clinical collateral.
• Lead the creation of scalable, role-specific training assets that support onboarding, skill progression, and advanced clinical use cases.
• Apply adult learning principles to the design of procedural education, ensuring content is practical, relevant, and immediately applicable to real-world clinical practice of urologists.
• Ensure consistency of messaging, visuals, and clinical claims across all training materials and channels.
• Create and maintain Instructions for Use (IFU) documents in collaboration with R&D, Clinical, and Regulatory partners.

 Develop, Scale & Support Hands‑On Product Demonstrations

• Define the strategy, standards, and intended learning objectives for hands-on product demonstrations, ensuring they clearly reinforce procedural best practices and product value propositions. 
• Conceptualize and prototype compelling product demonstrations—partnering with R&D and Clinical Development Engineering—to validate effectiveness. 
• Execute high‑quality demonstrations for customers (e.g., Key Opinion Leaders) and strategic stakeholders (e.g., investors). 
• Provide strategic guidance and quality oversight to other demo related resources, who independently executes day-to-day demo preparation, logistics, and delivery. 
• Partner with Operations to ensure scalable processes exist to distribute product demonstration tools to key conferences, events, and across sales and clinical teams. 

 Other Responsibilities

• Contribute to Calyxo’s culture of collaboration, respect, transparency, ethics, efficiency, high achievement, and fun.
• Perform additional duties as assigned.

 Who You Will Report To:

• Director, Product Management

Requirements:

• Bachelor’s degree or equivalent practical experience. 
• Minimum 5 years of related experience in Professional/Medical Education, Product Management, clinical specialist roles, sales training, or R&D; at least 7 years in the medical device industry. 
• Experience with innovative Class II or Class III medical devices preferred. 
• Strong analytical and creative problem‑solving skills with the ability to break down complex, ambiguous challenges. 
• Ownership mentality with the ability to drive projects in a fast‑paced, high‑growth environment. 
• Self‑motivated with outstanding project and time management skills and a passion for learning and impact. 
• Proven ability to communicate effectively across all levels of the organization and with external stakeholders. 
• Demonstrated field‑focused approach through travel with sales reps, participation in workshops, and engagement with customers. 
• Ability to travel approximately 30%. 
• Compliance with applicable county, state, and federal vaccination requirements. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary $145,000 - $160,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:

The Manufacturing Engineer supports the development, improvement, and sustainment of manufacturing processes for CVAC 2.0, with a focus on quality, efficiency, and scalability. This role collaborates cross‑functionally with R&D, Quality, and Manufacturing teams to implement process improvements, support production, and transition new products and processes into manufacturing. The position also contributes to documentation, validation, equipment support, and continuous improvement while ensuring regulatory compliance and product quality.

In This Role, You Will:

• Support technical projects leading to new/improved processes for CVAC 2.0.
• Collaborate cross-functionally with R&D, Quality, Manufacturing Assemblers/Technicians, and other functional areas to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability.
• Contribute to the design and development of manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
• Provide sustaining production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
• Train and support production personnel during transition of new products/processes to production.
• Create and update high-quality manufacturing process documentation and assure that processes and documentation follow established policies and procedures.
• Apply LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
• Assist in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment.
• Generate and modify component/assembly/equipment drawings using Solidworks.
• Support the execution of process and equipment validations (IQ/OQ/PQ).
• Coordinate with external vendors as needed.
• Perform routine equipment maintenance by following manufacturer’s instructions and established procedures.
• Communicate project status, schedule baselines, schedule issues, project risks, and major decisions across all company disciplines.
• Support product quality and support regulatory compliance.

Who You Will Report To:

• Principal Manufacturing Engineer

Requirements:

• Education: Bachelor of Science in Engineering or a combination of relevant education and experience
• 5+ years’ experience supporting medical device manufacturing
• Experience with electronic components/assembly in the context of medical device capital equipment.
• Work location: Pleasanton, CA
• Travel: up to 20%
• Full time employment
• Proven track record of leading and delivering highly technical projects in a cross functional environment.
• Experience working in a structured design process such as ISO9000 or FDA QSR and knowledge of regulatory approval process and requirements.
• Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485 or ISO9001 and EN46001.
• Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks.
• Desirable: Experience working with capital equipment having field upgradable software.
• Desirable: Experience with phased medical device product development process and performing design transfer.
• Desirable: Experience designing, building, and implementing manufacturing fixtures and processing aids.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary range of $125,000 - $135,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:  

The Director, Facilities & EHS is responsible for strategic leadership and oversight of all facilities operations, maintenance programs, and site‑level environmental and safety compliance to ensure a safe, reliable, and audit‑ready environment for the manufacturing of urological medical devices. In addition this role requires strong EHS experience and full ownership of site Environmental, Health, and Safety programs. This leader ensures a compliant and efficient environment supporting sterile and non‑sterile manufacturing in a highly regulated setting. 

In This Role, You Will: 

Facilities Leadership & Site Operations 

• Oversee all facilities operations, including building systems (HVAC, compressed air, utilities, water systems), preventive maintenance, and vendor management. 
• Ensure reliable operation of critical environments such as cleanrooms, controlled manufacturing areas, metrology spaces, and laboratories. 
• Lead facilities planning, budgeting, and execution of capital improvement projects, including expansions, equipment installations, and infrastructure upgrades. 
• Maintain facility readiness for audits, inspections, and certifications (OSHA, FDA, ISO 13485, notified bodies, state and local agencies, customers). 
• Manage security, access control, janitorial, and site services. 
• Manage pest control program for all facilities per quality procedures. 

Environmental, Health and Safety 

• Maintain compliance with environmental regulations related to chemical storage, hazardous waste, wastewater, and air emissions. 
• Oversee waste streams common in urology device manufacturing (e.g., IPA, polymers, lubricants, sterilization residues, packaging materials). 
• Manage hazardous waste vendors, manifests, and reporting. 
• Lead sustainability initiatives focused on reducing waste from sterile packaging, plastics, and energy‑intensive processes. 
• Develop and maintain EHS policies, procedures, and training tailored to manufacturing of urology devices (catheters, scopes, disposables, electromechanical systems). 
• Conduct risk assessments, job hazard analyses, and ergonomic evaluations for assembly, cleanroom operations, and equipment handling. 
• Lead incident investigations and drive corrective/preventive actions. 
• Oversee industrial hygiene programs, including exposure monitoring for chemicals, adhesives, sterilants, and particulates. 
• Manage emergency response programs, including spill response and medical emergencies. 

Medical Device & Urology‑Specific Responsibilities 

• Ensure facilities and EHS programs align with FDA, ISO 13485, and GMP requirements for sterile and non‑sterile urology products. 
• Support safe handling of materials commonly used in urology device manufacturing (e.g., IPA, silicone, hydrophilic coatings, lubricants, adhesives, biocompatible polymers). 
• Partner with R&D and Quality to assess facility and EHS impacts of new product introductions, including device coatings, sterilization methods, and electromechanical components. 
• Support audits and inspections from FDA, notified bodies, and customers. 
• Contribute to risk management activities where EHS intersects with product safety, including ISO 14971 considerations. 

Leadership & Collaboration 

• Serve as the site’s subject‑matter expert for facilities and EHS. 
• Provide coaching and training to employees, supervisors, and cross‑functional teams; lead safety committees and drive a culture of accountability and continuous improvement. 
• Develop and maintain facilities and EHS metrics, dashboards, and reporting for leadership. 
• Manage budgets, consultants, and external service providers. 

Who You Will Report To: 

•  Vice President, People 

Requirements: 

• Education: Bachelor’s degree in Engineering, Facilities Management, Environmental Science, Occupational Health & Safety, or a related field; or equivalent relevant work experience. 
• 10+ years of experience in facilities management and/or maintenance operations, with required EHS leadership experience in manufacturing, preferably within a regulated industry such as medical devices, pharmaceuticals, biotechnology, or related life sciences. 
• Strong knowledge of OSHA, EPA, and state/local regulatory requirements; experience with hazardous waste management, chemical handling, and emergency response; familiarity with medical device manufacturing environments including cleanrooms and sterile processing; ability to conduct risk assessments, job hazard analyses, and ergonomic evaluations; experience supporting FDA, ISO 13485, and GMP compliance; ability to lead incident investigations and implement corrective and preventive actions; and understanding of industrial hygiene principles, exposure monitoring, and control strategies. 
• Strong communication abilities; leadership presence; excellent problem‑solving and analytical thinking; high attention to detail; strong organizational skills; ability to follow instructions and manage multiple priorities; and a team‑oriented, continuous‑improvement mindset. 
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook); experience with EHS and facilities management systems such as incident tracking, CMMS, training platforms, and SDS databases; and the ability to interpret digital dashboards, metrics, and reporting tools. 
• Physical requirements include the ability to lift up to 10–25 pounds occasionally; stand, walk, or sit for extended periods (up to 8 hours/day); work in manufacturing and cleanroom environments while wearing required PPE; respond to emergencies including spill response and alarm situations; and work safely around chemicals, equipment, and other typical manufacturing hazards with appropriate protective equipment. 
• Work location: Pleasanton, CA (onsite) 
• Travel: <5% 
• Full time employment 
• Compliance with relevant county, state, and Federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary offering a generous annual base range between $220,000 and $240,000 and variable incentive plan 
• Stock options—ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

Summary:

Calyxo is seeking a highly skilled and innovative electrical engineer to help develop electronic subsystems in kidney stone treatment. This role focuses on the design of PCBAs, cable harnesses, and prototype embedded software for integration of sensing, controls, and communication subsystems into safe and reliable products. This is a hands-on technical leadership role for an engineer who enjoys developing both hardware and embedded software, working across electromechanical, controls systems, and software boundaries to deliver clinically robust performance. This role requires ensuring that all engineering efforts comply with industry standards and regulatory requirements, while aligning with strategic business objectives. 

In This Role, You Will:

• Develop electronic subsystems for a range of sensing, controls and communications applications in medical devices (disposable and capital)
• Translate system‑level requirements into schematics, PCBAs, cable assemblies, and interface definitions.
• Define electrical architectures including power distribution, sensing, actuation, safety interlocks, and diagnostics.
• Design low‑noise analog, mixed‑signal, high-speed and power electronics PCBAs for sensors, actuators, control and communication electronics.
• Specify and design custom cable harnesses (signal, power, shielding, grounding) suitable for medical environments.
• Ensure EMI/EMC robustness and compliance with applicable medical standards (e.g., IEC 60601‑1‑2).
• Select sensor, actuator, power electronics, and protection components for controls systems with attention to accuracy, drift, long term reliability, environmental exposure (heat, fluids, cleaning agents), component lifecycle, and applicable derating/tolerancing
• Prototype and debug embedded control algorithms for real-time closed-loop control systems (PID, feed forward, fault detection, control limits)
• Collaborate with firmware/software teams to define hardware/firmware interfaces and control strategies
• Support bring-up, tuning, and characterization using lab instrumentation and test fixtures.
• Support electrical and system‑level verification and validation testing, including IEC 60601-1 and 60601-1-2 compliance testing
• Contribute to risk analyses (FMEA) with focus on safety‑critical failures.
• Support troubleshooting during integration, verification testing, and clinical simulation
• Provide technical oversight to contract design houses and manufacturing partners, including review of schematics, layouts, design changes, test plans, and documentation, ensuring adherence to design intent, quality expectations, and regulatory requirements
• Interact with suppliers and internal operations representatives to perform design transfer, root cause investigation, component lifecycle management, and continuous improvement.
• Partner closely with clinical development engineering, product management, quality, regulatory and other cross-functional teams to bring designs to the market.
• Mentor junior and non-specialist engineering talent, promoting a collaborative and high-performance work environment.

Who You Will Report To: 

• Director, Vision and Sensor Systems

Requirements:

Education & Experience

• Bachelor’s degree in Electrical Engineering. Master’s preferred.
• 8+ years of experience in electronic subsystem design in a regulated product environment; working knowledge of IEC 60601‑1, IEC 60601‑1‑2, and ISO 14971 concepts strongly preferred.
• Analog and mixed‑signal circuit design (sensor front‑ends, signal conditioning).
• Power electronics and power management (DC‑DC, linear regulation, protection).
• PCBA design using modern EDA tools (schematic capture, layout review). Altium experience preferred.
• Design of electrical interfaces for closed-loop control system components (sensors, pumps, valves, heaters). Exposure to manufacturing, DFM/DFT, and field failure analysis of these interfaces strongly preferred.
• Hands‑on prototyping, debugging, and lab test methodologies.
• Understanding of EMI/EMC, grounding, and cabling best practices.
• Experience in embedded systems design and hardware/firmware co‑
• Proficiency in embedded software development (C/C++) and scripting for hardware automation and data analysis (Python). Experience with STM32 applications preferred.
• Prior experience implementing closed‑loop control concepts (PID tuning, stability, disturbance rejection), with exposure to sensor calibration, drift management, and fault detection strategies.
• Familiarity with design controls, design reviews, and change management.
• Experience supporting requirements definition, verification testing and risk management. Application of these concepts to safety-critical or redundant system design preferred.
• Prior ownership of hardware through full lifecycle (concept through sustaining).
• Proven ability to lead technical workstreams, including experience managing and reviewing work performed by external contractors or partners.
• Strong documentation, presentation, and cross‑functional communication skills.
• Must be self-directed, self-motivated and be able to multi-task in a fast-paced environment with multiple priorities.
• Ability to travel domestically and internationally up to 10% of the time.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary range of $165,000 - $175,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:  

The Academic Engagement Manager supports the execution of Calyxo’s professional education and physician engagement programs across academic training programs, peer‑to‑peer initiatives, and society meetings. Reporting to the Director of Professional Education, this role partners cross‑functionally to coordinate educational programs for residents, fellows, emerging faculty, and key opinion leaders (KOLs). The manager helps ensure smooth program delivery, consistent documentation, and high‑quality experiences for healthcare professionals (HCPs) participating in Calyxo educational activities. This role supports Calyxo’s commitment to high‑quality physician education and engagement and helps drive awareness of Calyxo products. 

In This Role, You Will:  

Academic & Training Programs 

• Collaborate with the Director, Professional Education to support Calyxo physician engagement initiatives by developing and delivering educational programs for residents, endourology fellows, emerging thought leaders, academic faculty, and KOLs, while building relationships as they progress into early career roles. 
• Support educational grant initiatives, including preparing and submitting grant applications, tracking status and approvals, and coordinating reviews and communication with the Compliance Committee. 
• Collaborate with fellowship and residency program administrators and directors to support educational initiatives and ensure program alignment. 
• Develop and maintain academic program profiles, including faculty details, curricula, engagement history, and communication records. 
• Partner with field teams to execute local educational initiatives, including journal clubs and hands‑on lab programs. 

Physician Engagement and Faculty Support 

• Assist with management of speaker logistics, agreements, honoraria, and expense documentation. 
• Partner with MCA and cross‑functional teams to coordinate physician preparation for society presentations and other meeting presentations, including stakeholder alignment and presentation‑readiness activities. 
• Monitor agendas and discussion topics for local and regional meetings to help ensure speakers are prepared with current, accurate information. 
• Attend physician presentations at scientific meetings and programs to capture feedback, summarize key insights, and share observations with internal teams. 
• Develop, foster, and maintain relationships with KOLs in the endourology field. 

Peer-to-Peer 

• Support program planning and execution, including logistics for HCP educational programs, peer‑to‑peer events, and hands‑on trainings. 
• Support field and faculty communication and post‑program follow‑up activities. 
• Coordinate program materials and content, equipment, venue logistics, and (if applicable) customer travel. 
• Support faculty onboarding and preparation to ensure consistent Calyxo messaging. 
• Assist with program reporting, tracking attendance, budget monitoring, and documentation. 

Program and Cross‑Functional Collaboration  

• Work closely with Marketing, Sales, Commercial Acceleration, Compliance, and Clinical/Medical Affairs to ensure alignment and smooth execution of all professional education activities. 
• Participate in society meetings, forums, and symposia, as well as educational and scientific program planning meetings, to support product and procedural awareness and guideline development. 
• Assist in collecting and organizing program feedback, metrics, and performance insights for continuous improvement and needs assessments. 

Who You Will Report To: 

•  Director, Professional Education

Requirements: 

• Bachelor’s degree with 6 years of experience; equivalent combinations of education and experience will also be considered. 
• 3–5 years of experience in medical devices, healthcare education, training, or a related field. 
• Experience supporting professional education, training programs, or events strongly preferred. 
• Strong organizational skills with the ability to prioritize, manage multiple projects and adapt as needed.  
• Excellent communication and interpersonal skills with a customer‑service mindset. 
• Urology experience is a plus. 
• Ability to travel 30–40%. 
• Effective interpersonal interactions, both within the commercial group and in accounts. 
• Proficiency with PC-based office computers, including familiarity with Adobe, Microsoft Word, Excel, PowerPoint, and Outlook required. 
• Experience with video editing and Adobe Premiere preferred. 
• Ability to work with minimal supervision. 
• Valid driver’s license. 

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.  

We also offer an attractive compensation package, which includes

• A competitive base salary range of $130,000 to $150,000 and a variable incentive plan  
• Stock options—ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance, and paid vacation 

Summary:  

We are seeking a Senior Marketing Manager to translate strategic messaging and clinical insights into high-impact tools, programs, and resources that drive field adoption of the CVAC System. 

This role will partner closely with Sales Leadership and Field Training to ensure the commercial team is equipped with compelling, practical, and differentiated materials that support physician engagement and procedural adoption. 

In This Role, You Will:  

• Translate messaging frameworks into sales tools, presentations, and training materials in close partnership with Sales Leadership and Sales Training  
• Own sales enablement strategy and execution across key initiatives  
• Develop tools that support clinical conversations and objection handling in real-world customer interactions 
• Ensure materials are practical, usable, and aligned with field workflows and feedback 
• Support national meetings, trainings, and field communications  
• Gather field feedback and continuously refine tools for effectiveness  

Cross-Functional Collaboration 

• Partner closely with Sales Leadership and Field Training to develop and deliver field-ready tools, programs, and communications that support physician engagement and procedural adoption  
• Act as a key stakeholder with Strategic Marketing to translate messaging frameworks and positioning into practical, customer-facing materials  
• Collaborate with MarCom to ensure all deliverables are high-quality, on-brand, and effectively executed across formats and channels  
• Work cross-functionally with internal teams as needed (e.g., Medical and Clinical Affairs, Market Access, Product Management) to ensure materials are accurate, relevant, and aligned with broader commercial strategy  

What Makes This Role Different 

• Focused on execution and adoption  
• Requires strong understanding of how the field engages physicians, drives evaluation, and supports adoption of procedures and technologies 
• Success is measured by field utilization and impact, not just output 

Who You Will Report To:   

• Sr. Director, Commercial Marketing

Requirements:

• Education: Equivalent work experience or Bachelor’s degree in marketing, business administration, or a related field; MBA preferred  
• Minimum of 7+ years of experience in downstream marketing, sales enablement, or commercial roles within the medical device industry  
• Excellent communication and interpersonal skills with the ability to collaborate effectively with Sales, Training, and cross-functional teams 
• Ability to translate strategic direction and market insights into clear, compelling, and practical sales enablement materials 
• Results-oriented with a focus on driving field adoption, utilization of tools, and commercial impact  
• Knowledge of regulatory requirements and compliance standards for medical devices, with the ability to ensure all sales materials meet appropriate guidelines  
• Ability to translate clinical messaging into clear, field-ready value propositions and customer-facing materials 
• Ideally a hybrid background in sales + marketing  
• High bias for action and practical execution 
• Work Location: Pleasanton  
• Travel: 25% travel   

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.  

We also offer an attractive compensation package, which includes

• A competitive base salary range of $180,000 to $195,000 and a variable incentive plan  

• Stock options—ownership and a stake in growing a mission-driven company 

• Employee benefits package that includes 401(k), healthcare insurance, and paid vacation 

Summary:

The People Team Coordinator is an enthusiastic, energetic communicator who thrives on building connections and bringing out the best in the people around them. With exceptional oral and written communication skills the Coordinator provides vital administrative support to the People Team and  the Talent Acquisition team – helping keep our daily operations running smoothly and with a smile. At Calyxo, we believe that a great workplace starts with great people, and the People Team Coordinator is at the heart of that mission.  The role is all about championing our culture –  streamlining processes, sharing exciting employee offerings and spreading the word about our initiatives and programs that make Calyxo a place employees love to work. If you find joy in helping others, going the extra mile to improve someone’s day and being the face of a dynamic team, this role is for you.  This is an in-office position based in Pleasanton, CA. 

In This Role, You Will: 

• Support Talent Acquisition by ensuring a positive candidate experience when candidates engage with Calyxo. 
• Schedule candidate interviews, maintain ongoing communication with hiring managers, interview team, and candidates. Coordinate logistics and fill gaps during the recruiting process. 
• Assist with updating and maintaining Greenhouse, Calyxo’s applicant tracking system. 
• Initiate background checks, trigger onboarding process in HRIS, and manage I9 verification process for all new joiners. 
•  Assist with the employee termination process when appropriate – documentation preparation and coordinating exit procedures.Collaborate with People Team members to ensure a positive onboarding experience including proactive communication around timelines, due dates, and what to expect before and during onboarding. 
• Monitor onboarding systems to ensure new hires are completing tasks by the required due dates. Support day-to-day employee lifecycle processes such as onboarding, data changes, and offboarding by maintaining accurate employee records in HR systems and ensuring timely completion of transactions. 
• Assist in reviewing and improving People team workflows and documentation to enhance efficiency, compliance, and employee experience. 
• Assist with ad hoc projects and reports as needed such as monthly headcount reports and All Employee Meeting materials. 
• Create credentialing letters for all commercial new hires. Update letters and order drug tests, as needed. 
• Assist with Employee Engagement activities 
• Provide administrative support to the whole People Team. 

Who You Will Report To:

• Vice President, People

Requirements:

• Education: 4-year college degree or equivalent experience 
• Experience: minimum 2 years HR admin and/or coordinator experience  
• Work location: Pleasanton, CA 
• Travel: <5% 
• Full time employment 
• Experience working on projects in a cross-functional environment. 
• Exceptional oral and written communication skills 
• Excellent computer skills with multiple programs including the Microsoft Office Suite. 
• Intermediate level skill in Microsoft Excel (eg, using SUM function, setting borders, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling).  
• Intermediate level skill in Microsoft Word (eg, inserting headers, page breaks, page numbers and tables and/or adjusting table columns). 
• Intermediate level skill in PowerPoint (building professional slide decks with above-average graphics, layouts, images) 
• A natural self-starter with a genuine curiosity and drive to dig in, figure things out, and find solutions – someone who takes initiative without waiting to be asked 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

Preferred Qualifications: 

• Experience with platforms including Greenhouse, HiBob, and Paylocity. 
• Working knowledge of Microsoft SharePoint for building and maintaining internal intranet pages, document libraries, and HR knowledge resources. 
• Experience working in a customer service oriented/administrative environment. 
• Knowledge of v-lookups and other advanced Microsoft excel skills. 

 What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary of $85,000 - $95,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

 Summary:  

The Sr. Manager, Commercial Pricing & Operations, will play a critical role in building and owning the company’s pricing and contract reporting infrastructure. This position will support the commercial organization by ensuring pricing accuracy, contract compliance, rebate processing, and pricing analytics while serving as the operational owner of pricing data across Salesforce, NetSuite, Enable, and reporting platforms. 

This role will also serve as the business lead and PMO partner for the implementation of a Salesforce CPQ (or equivalent quoting) solution, helping design scalable quote-to-cash workflows and pricing governance processes (in partnership with cross-functional stakeholders).  

This is a hands-on role suited for a growing organization, where the individual will combine analytics, pricing operations, and cross-functional collaboration to support sales growth and pricing discipline.  

In This Role, You Will: 

Pricing Operations 

• Own the internal pricing administration process, including price list updates for new products and ongoing maintenance, contract price loading, and pricing validation across systems. 
• Manage pricing data within Salesforce, NetSuite, and pricing tools, ensuring consistency and accuracy. 
• Support review and approval of special pricing requests and discount structures in accordance with sales team pricing approval matrix. 
• Maintain internal pricing tables and discount frameworks used by Sales and Finance. 
• Monitor pricing discrepancies and resolve issues with Sales, Sales Operations, Customer Service, Business Intelligence, and Finance teams. 

Contract & Rebate Administration 

• Drive the pricing contract lifecycle process, including rebate and contract verification, amendments, and updates across Enable, Salesforce, and NetSuite. 
• Act as liaison between Sales, Sales Operations and Accounts Receivable to ensure accurate rebate calculations and timely payments. 
• Validate rebate eligibility, track rebate accruals, and assist with reconciliation processes. 
• Maintain contract membership data (e.g., hospital systems, GPO participation). 
• Coordinate contract pricing updates with internal stakeholders. 

Customer Report Validation & Ownership 

• Own the validation and distribution of customer-facing reports, including utilization reports, rebate reports, and contract performance summaries. 
• Ensure data accuracy between internal systems and customer reporting outputs. 
• Investigate discrepancies between internal sales data and customer-submitted utilization reports. 
• Work with Sales and Finance to resolve customer reporting questions and audit requests. 

Pricing Analytics & Management Reporting 

• Collaborate with Sales Operations and Business Intelligence to build a pricing and contract dashboard for Sales leadership visibility. 
• Provide analytics on pricing performance, Rebate/discount trends and contract utilization. 
• Deliver data-driven insights to Sales leadership to inform pricing decisions and contract negotiations. 
• Monitor pricing KPIs and communicate findings to commercial leadership. 

Quoting/CPQ Implementation & Quote-to-Cash Process 

• Serve as the commercial operations project manager leading the implementation of a quoting (CPQ or other) platform within Salesforce. 
• Define and translate business requirements for pricing rules, approval workflows, contract price logic, and quoting processes. 
• Support testing, rollout, and adoption of quoting tools. 
• Work with internal teams and consultants to improve quote-to-cash workflow efficiency. 

Process Improvement 

• Develop standard operating procedures (SOPs) for pricing and contract administration. 
• Identify opportunities to streamline pricing workflows and reduce manual processes. 
• Improve visibility and governance around pricing approvals and contract compliance. 

Who You Will Report To: 

•   Sr. Director, Customer Service

Requirements: 

• 8+ years of experience in pricing, contracts, commercial operations, or revenue operations. 
• Experience in medical device, healthcare, or life sciences industry. 
• Experience supporting pricing administration, contract pricing, or rebate processes. 
• Understanding of GPO contracts, hospital pricing, rebates, and distributor pricing. 
• Experience supporting customer reporting and contract compliance. 
• Strong analytical skills and experience working with commercial data. 
• High degree of accuracy and attention to detail. 
• Excellent organizational skills with the ability to prioritize assignments while handling various projects simultaneously. 
• Strong oral, written and interpersonal communication, with the ability to work effectively in a lead role with cross functional teams. 
• Proficiency in MS Word, PowerPoint, and advanced Excel. 

Preferred 

• Experience with Salesforce CPQ or other quoting platforms. 
• Experience with BI tools such as Tableau or Power BI. 
• Experience working with CRM systems, Salesforce, and ERP systems such as NetSuite. 

Key Traits for Success 

• Detail-oriented with strong data validation skills. 
• Comfortable leading cross function project teams across Sales, Sales Ops, Finance, Legal, Business Intelligence and Customer Service. 
• Strong operational mindset with ability to build processes in growing organizations. 
• Ability to balance analytics and operational execution. 

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

We also offer an attractive compensation package, which includes: 

• A competitive base salary range of $145,000 - $175,000 and variable incentive plan  
• Stock options – ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation 

Summary:

The Advanced Development team is responsible for early stage development and risk retirement of high risk and high reward design concepts. This team will develop proven ideas that work into the product development pipeline.

In This Role, You Will:

• Invent and evaluate early stage concepts. You will be asked to push limits and come up with creative and ground breaking solutions
• Lead the design, development, and testing of of critical electromechanical and fluidics systems and subsystems for an innovative kidney stone treatment device.
• Drive early phase product design concept ensuring manufacturability, reliability, scalability, and cost-effectiveness.
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory, Clinical, and Marketing) to create solutions that best meets user needs.
• Develop test methods, create specifications, and execute early phase feasibility testing, including writing reports and documentation.
• Ensure compliance with FDA regulatory standards, maintaining adherence to the design control process throughout the product development lifecycle.
• Use SolidWorks to perform engineering calculations, create detailed models, and optimize product designs for manufacturing.
• Communicate project status, risks, and milestones effectively across all relevant departments.
• Collaborate with suppliers and internal teams to ensure product quality and seamless production.

Who You Will Report To:

• Vice President, Advanced Development

Requirements:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field and a minimum of 6 years of medical device experience, OR
• Master’s degree in a related field and a minimum of 5 years of medical device experience, OR
• PhD in a related field and a minimum of 3 years of medical device experience.
• Experience with early concept and design development of innovative medical devices, including brainstorming, feasibility assessments, and prototyping.
• Understanding of medical device regulations, including ISO 13485, FDA 21 CFR Part 820 (for design controls and quality management), as well as best practices for mechanical design validation and risk management.
• Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance analysis, and cost optimization.
• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.
• Strong problem-solving and analytical skills, with a hands-on approach to product development and testing
• Demonstrated ability to innovate and create solutions with incomplete or ambiguous requirements
• Work location: Pleasanton, CA
• Travel: less than 10%
• Full time employment
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

 What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary range of $140,000 - $160,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:  

The Clinical Project Manager plays a critical role in leading the execution of clinical trials from start to finish. This position ensures trials are conducted efficiently, on time, and in full compliance with regulatory requirements. This position collaborates closely with internal stakeholders and external partners—including CRAs, CROs, and clinical sites—to generate high-quality clinical evidence that informs product development and regulatory strategy. This is a hands-on role within a fast-paced, team-driven environment, ideal for candidates who thrive in dynamic settings and have a passion for operational excellence in clinical research.  

In This Role, You Will: 

• Ability to effectively manage clinical studies to support the clinical operation goals that align with the company’s visions for evidence generation 
• Ensure clinical research is conducted in accordance with 21 CFR Part 812, 50 and 56 and applicable international standards (ISO 14155:2026) 
• Identify, evaluate and qualify clinical sites to ensure compliance with applicable regulatory regulations 
• Assist in negotiating clinical site budgets and study contracts 
• Prepare clinical monitoring guidelines 
• Generate various study and training materials to support clinical trials 
• Source, manage and train contract CRAs assigned to study sites 
• Review and approve CRA monitoring trip reports 
• Conduct site initiation visits and monitoring visits, and provide clinical trial related training for RCs, Investigators, OR staff, etc. 
• Provide surgical technique training and proctor clinical cases at hospital and ASC facilities 
• Plan and conduct investigator meetings 
• Assist in identifying, evaluating and managing CROs or vendors for study related services including but limited to: data management, statistical analysis, monitoring 
• Provide technical eDC and clinical support during clinical research 
• Monitor clinical study data and assist in cleaning of eDC and other study databases 
• Develop project management tools to manage clinical projects 
• Develop study tracking tools and metrics and report to management 
• Conduct and summarize literature reviews in support of clinical activities 
• Assist with coordination of data analysis and prepare clinical reports to support regulatory filings 
• Assist with development of clinical strategy, which includes the preparation of clinical protocols and investigational plans. 
• Other duties may be assigned as a part of job scope 

Who You Will Report To: 

• Sr. Director, Clinical Operations

Requirements: 

• Degree in a life science (BS or MS) 
• 7+ years of relevant clinical experience in medical devices (or a combination of pharma and med devices)   
• At least four years of full-cycle clinical project management experience. 
• Intimate working knowledge of US clinical research and medical device regulations.  
• Ability to effectively work cross-functionally with multiple departments; manage completion of multiple tasks.   
• Ability to prioritize projects and display initiative and flexibility.   
• Detail oriented, strong people and organizational skills.  
• Strong medical background and understanding of the fundamentals of clinical research and statistical methodology.  Background in urology research preferable.  
• Proficient with PC and associated software. Strong technical, written and communication skills. 
• Ability to travel up to 50% of the time 
• Proficiency in Power Point, Excel and eDC platforms 
• Compliance with relevant county, state, and Federal rules regarding vaccinations. 

 What We Offer: 

 At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

 We also offer an attractive compensation package, which includes: 

• A competitive base salary range of $140,000 - $150,000 and variable incentive plan  
• Stock options – ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation 

Summary:

This role serves as the primary point of contact between customers, sales, and internal teams, ensuring accurate and timely order fulfillment while maintaining high levels of customer satisfaction. By managing order workflows, resolving service issues, and supporting related processes such as account setup and equipment tracking, this position plays a critical role in driving operational efficiency and supporting overall business success.

In This Role, You Will:

• Responsible for customer order fulfillment, open order management, service issues and resolution, while acting as primary liaison between customers, sales and cross functional departments. Generate weekly report for sales on open billable orders.
• Review and maintain open orders to quickly resolve delivery blocks, billing blocks, and incomplete order status. Provide accurate documentation of all delays and changes made to an order.
• Collaborate with Customer, Sales, Legal and Finance to support the New Account setup process
• Work with 3PL, supply chain, sales as needed to manage customer expectations and ensure order fulfillment requirements are met and system records are updated.
• Maintain Customer Equipment records and facilitate the upgrade process when appropriate.
• Support Equipment Evaluation program and coordinate the shipment, return or purchase conversion with Sales and Customers.
• Investigate and process Credits, Debits and Returned Goods Authorizations in a timely manner.
• Facilitate trunk stock requests and conduct monthly trunk stock audits and reconciliation with sales. Generate monthly reports to leadership on reconciliation performance.
• Ensure customer satisfaction by answering incoming/outbound calls and emails in a friendly, engaged and enthusiastic manner.
• Review and respond to all emails with professionalism, accurate information and timely follow up.
• Document customer interactions by recording details of any inquiries, requests or feedback per Standard Operation Procedures.
• Maintains knowledge of and adheres to all processes, policies and procedures.
• Escalates issues as necessary for guidance from others.
• Work with Customer Service Management in identifying and documenting areas of process changes and/or improvements.
• Other duties as assigned.

Who You Will Report To:

• Customer Service Manager

Requirements:

• Education: High school diploma
• Minimum 5 year's experience in a customer service role or equivalent combination of education and experience
• Work location: Remote (West Coast)
• Travel: 10%
• Full time employment
• Excellent interpersonal and phone etiquette skills.
• High degree of attention to detail and ability to multi-task in a fast-paced environment
• Problem Resolution, follow-up, planning and organizational skills, including ability to meet deadlines.
• Must be able to work independently and on a team utilizing effective time management.
• Must be proficient with typing and the use of MS Word, Excel, Outlook, Teams.
• Must have ability to learn quickly and adapt to new technologies and applications.
• Netsuite, SalesForce, QuickBooks system experience preferred
• Must be able to work at a computer workstation for extended periods of time.
• Medical Device experience required.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive hourly rate between $28.46 - $33.65 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary: 

The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment. 

The Clinical Specialist will train the surgical team on instrument preparation prior to cases and during the surgical procedure. This role will manage inventory needs in the account and any accompanying administrative requirements.  

This role is not considered for pathway to a Territory Sales Manager at Calyxo Inc, due to the tenure and experience required to execute the Territory Sales Manager role. 

Ideal candidates will live in the targeted geographical area.  

This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales training programs. 

In This Role, You Will: 

• Provide clinical case coverage as assigned 
• Train the surgical team to assist in good patient outcomes and verbally support cases during training period 
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital policies and procedures 
• Develop technical acumen to a level to serve as an educational resource 
• Demonstrate appropriate interactions with all hospital service providers 
• Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits 
• Troubleshoot equipment according to standard procedure 
• Provide intra-operative clinical product support 
• Ensure that 100% of received inventory and returned inventory matches shipping documents 
• Reconcile inventory/usage as well as missing inventory 
• Assist in the delivery of procedural training to physicians and medical staff 
• Be an effective member of the commercial team and play a key role in ensuring positive clinical outcomes 
• In partnership with TSM, perform account management: such as Account Set Up, Clinical Engagement, Case Support and Clinical Outcomes  
• In Partnership with TSM, support education of APPs, Office and Hospital Staff 
• In partnership with TSM, help facilitate and support Residency Education 
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with health care professionals 
• In this role, you will collaborate with Clinical Specialist teams to review and discuss case presentations and peer to peer knowledge sharing 
• Other duties as assigned 

 Who You Will Report To: 

•  Regional Clinical Manager (RCM) 

 Clinical Specialist I Requirements: 

• Clinical experience such as: 
  • Scrub Tech 
  • X-Ray Tech 
  • RN or BSN 
  • Laser Tech 

Clinical Specialist II Requirements: 

• In addition to all of the above: 
• Industry experience (1-3 years) 
• Prior Employment as a Clinical Specialist with a medical device company or experience working with Mobile Litho Provider Companies 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Willingness to travel outside of the designated territory 

Sr. Clinical Specialist Requirements: 

• In addition to all of the above 
• Industry experience: 3+ years of full-time employment by a medical device company as a clinical specialist (or comparable position) focused on case coverage and patient outcomes (not equipment/service provider). 
• Clinical experience: Intraoperative Coaching Experience 
• OR experience: Fluent in Staff and Support Training 
• Track record of success. Urology experience preferred. 
• Understands the medical device industry 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Understands sales processes and training 
• Willingness to travel outside of the designated territory  

General Requirements:  

• Experience in surgical technique and sterile procedures in the operating room 
• Experience utilizing fluoroscopy is a plus 
• Customer relationship and procedural skill development are highly desired 
• Highly desirable candidates will have a degree or certification in a medical-related field (ex: LPN, RN, Surg Tech, Rad Tech, etc). 
• Able to travel by car up to 90% 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary
  • Total Compensation: $100,000 - $140,000 annually
    • Base Salary: $80,000, $100,000, or $120,000 per year (DOE)
    • Annual Variable Bonus: $20,000
  • Plus, generous allowances such as:
    • Auto Allowance: $9,600
    • Cell Phone/Internet Allowance: $1,800
• Stock options: ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary: 

The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment. 

The Clinical Specialist will train the surgical team on instrument preparation prior to cases and during the surgical procedure. This role will manage inventory needs in the account and any accompanying administrative requirements.  

This role is not considered for pathway to a Territory Sales Manager at Calyxo Inc, due to the tenure and experience required to execute the Territory Sales Manager role. 

Ideal candidates will live in the targeted geographical area.  

This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales training programs. 

In This Role, You Will: 

• Provide clinical case coverage as assigned 
• Train the surgical team to assist in good patient outcomes and verbally support cases during training period 
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital policies and procedures 
• Develop technical acumen to a level to serve as an educational resource 
• Demonstrate appropriate interactions with all hospital service providers 
• Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits 
• Troubleshoot equipment according to standard procedure 
• Provide intra-operative clinical product support 
• Ensure that 100% of received inventory and returned inventory matches shipping documents 
• Reconcile inventory/usage as well as missing inventory 
• Assist in the delivery of procedural training to physicians and medical staff 
• Be an effective member of the commercial team and play a key role in ensuring positive clinical outcomes 
• In partnership with TSM, perform account management: such as Account Set Up, Clinical Engagement, Case Support and Clinical Outcomes  
• In Partnership with TSM, support education of APPs, Office and Hospital Staff 
• In partnership with TSM, help facilitate and support Residency Education 
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with health care professionals 
• In this role, you will collaborate with Clinical Specialist teams to review and discuss case presentations and peer to peer knowledge sharing 
• Other duties as assigned 

 Who You Will Report To: 

•  Regional Clinical Manager (RCM) 

 Clinical Specialist I Requirements: 

• Clinical experience such as: 
  • Scrub Tech 
  • X-Ray Tech 
  • RN or BSN 
  • Laser Tech 

Clinical Specialist II Requirements: 

• In addition to all of the above: 
• Industry experience (1-3 years) 
• Prior Employment as a Clinical Specialist with a medical device company or experience working with Mobile Litho Provider Companies 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Willingness to travel outside of the designated territory 

Sr. Clinical Specialist Requirements: 

• In addition to all of the above 
• Industry experience: 3+ years of full-time employment by a medical device company as a clinical specialist (or comparable position) focused on case coverage and patient outcomes (not equipment/service provider). 
• Clinical experience: Intraoperative Coaching Experience 
• OR experience: Fluent in Staff and Support Training 
• Track record of success. Urology experience preferred. 
• Understands the medical device industry 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Understands sales processes and training 
• Willingness to travel outside of the designated territory  

General Requirements:  

• Experience in surgical technique and sterile procedures in the operating room 
• Experience utilizing fluoroscopy is a plus 
• Customer relationship and procedural skill development are highly desired 
• Highly desirable candidates will have a degree or certification in a medical-related field (ex: LPN, RN, Surg Tech, Rad Tech, etc). 
• Able to travel by car up to 90% 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary
  • Total Compensation: $100,000 - $140,000 annually
    • Base Salary: $80,000, $100,000, or $120,000 per year (DOE)
    • Annual Variable Bonus: $20,000
  • Plus, generous allowances such as:
    • Auto Allowance: $9,600
    • Cell Phone/Internet Allowance: $1,800
• Stock options: ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:

We are seeking an experienced Senior NetSuite System Administrator to serve as the subject matter expert and owner of our NetSuite ERP platform. This role is critical to supporting and scaling our Finance, Operations, Supply chain, Customer service and Commercial processes as the company grows.

The ideal candidate brings deep functional knowledge of order‑to‑cash (O2C) and procure‑to‑pay (P2P) processes, strong hands‑on NetSuite administration skills, and the ability to partner closely with Finance, Operations, Supply Chain, Customer Service, Commercial, and IT teams. Experience working in a high‑growth or regulated environment is strongly preferred.

In This Role, You Will:

NetSuite Ownership & Administration

• Serve as the primary system administrator and functional owner of NetSuite including managing roles, permissions, users, approval hierarchies, and system security.
• Configure, maintain, and optimize NetSuite workflows, custom fields, and forms within Order‑to‑Cash (O2C)
• Optimize end‑to‑end O2C processes, including support and enhance EDI integrations (quoting, sales orders, invoicing, and fulfillment processes).
• Partner with Finance, Customer Service and Commercial teams to ensure accurate billing, revenue reporting, and compliance.
• Troubleshoot and resolve transactional or data integrity issues within O2C workflows.

Procure‑to‑Pay (P2P)

• Support and enhance P2P processes including vendor setup, purchase orders, receiving, AP, and payment runs.
• Work closely with Finance, Supply Chain, and Operations to improve efficiency, controls, and visibility.
• Assist with inventory management process and warehouse workflow to scale effectively with company growth.

Integrations & Automation

• Support and maintain system integrations between NetSuite and upstream/downstream systems.
• Collaborate with technical teams and vendors on integration design, monitoring, and issue resolution.
• Familiarity with Celigo or similar iPaaS tools is a strong plus, particularly for ERP integrations.
• Monitor new capabilities offered by Netsuite (i.e. AI workflows) and propose to the cross functional team based on business needs.

Reporting, Controls & Compliance

• Develop and maintain saved searches, reports, and dashboards to support Finance, Customer Service and Operations.
• Assist with data imports, system clean-up, and ongoing optimization projections
• Support internal controls, audits, and system documentation, especially in a regulated medical device environment.
• Participate in NetSuite release management, testing, and impact assessments.

Cross‑Functional Partnership

• Translate business requirements into scalable NetSuite solutions.
• Provide user training, documentation, and ongoing system support to internal teams (Finance, Customer Service, Supply chain, Commercial, and IT stakeholders) and improve system functionality.
• Other duties as assigned by manager

Who You Will Report To:

• Director, Business Intelligence

Requirements:

• 8+ years of hands-on experience administering NetSuite in a production environment.
• Deep, hands‑on knowledge of order‑to‑cash and procure‑to‑pay business processes.
• Strong understanding of NetSuite configuration, workflows, saved searches, and reporting.
• Proven experience partnering with Finance, Customer Service and Operations teams.
• Background in medical device, life sciences, or other regulated industries.
• Excellent problem‑solving, communication, and organizational skills.
• Excellent organizational skills with the ability to prioritize assignments while handling various projects simultaneously.
• Strong oral, written and interpersonal communication, with the ability to work effectively in a lead role with cross functional teams.

Preferred Skills

• Experience in a fast‑growing startup or scaling organization.
• Experience supporting integrations using Celigo (or similar integration platforms).
• NetSuite Administrator or SuiteFoundation certifications are highly preferred.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary range of $140,000 - $160,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:

You will serve as Project Manager and play a leadership role in maintaining our kidney stone treatment systems, accountable for leading multi-disciplinary teams in operational and sustaining improvements. You will plan for long-view work, balance day-to-day issues as they arise, define schedules, share information widely with team members and stakeholders, and foster healthy, productive teams. You will help us pursue ‘No stone left behind’! 

Your experience in operations and sustaining support for devices and capital equipment will facilitate your success. Your excellent PM skills, predictive/waterfall and adaptive/scrum work management methods, collaborative approaches and attention to social cues will keep everyone engaged and productive. Work examples: CVAC device, CVAC vision system, sustaining improvements, cost reduction, supply chain mitigations. You have led work from idea to production cut-in.

In This Role, You Will:

• Communicate with clarity and impact: Provide visibility on project progress, decisions, dependencies, risks, and timelines to teams and senior staff. Ensure transparency through excellent written and verbal communication.
• Develop and drive cross-functional alignment: Facilitate agreement among engineering, operations, supply chain, quality, commercial and regulatory on scope, priorities, and value delivery to achieve project objectives.
• Own execution: Lead planning and delivery of multiple, concurrent projects. Define objectives, success metrics, and guide internal and external contributors to execute effectively while adapting to changing conditions.
• Foster collaboration and trust: Build strong relationships across teams and levels to encourage knowledge sharing, accountability, and positive work habits.
• Enable technical delivery: Coordinate development activities. Manage prioritization, define “Done,” and lead planning and retrospectives for predictable delivery.
• Manage risks and remove obstacles: Anticipate challenges and eliminate barriers to progress. Apply structured risk-based decision-making, contingency planning, and trade-off analysis to maintain momentum.
• Champion process improvement: Contribute to evolving project management practices and tools tailored to organizational culture, driving efficiency and scalability.
• Support portfolio planning: Partner with stakeholders to forecast future project delivery, update routinely, and balance resource capacity against active programs, ensuring successful execution across multiple initiatives.

Who You Will Report To:

• Director, Program Management, R&D

Requirements:

• Education: BS Engineering/Science degree or equivalent required
• Minimum 5+ years total experience; medical device development experience strongly preferred
• Work location: Pleasanton, CA office
• Travel: ~10%
• Full-time employment
• Hard Skills: experience with operational support of on-market products, and development & cut-in of improvements for hardware, firmware & capital systems. Familiarity with FDA submission process, QMSR requirements. Proficiency in MS Office, Atlassian/JIRA, Monday.com and other PM tools.
• Soft skills: strong facilitation and communication skills across technical and executive audiences. Ability to lead cross-functional teams and influence without direct authority. Naturally accountable and organized.
• Physical requirements: Must be able to sit for up to 8 hours/day and operate standard office equipment.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary $130,000 - $140,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:

The Instruments Engineering team is a highly energetic and actively growing team that is responsible for developing and ultimately driving Calyxo’s instruments and accessories through to launch. In this role, you will drive the design and development of new solutions for both released and next-generation critical components and accessories, integrating these solutions alongside the vision, sensors, and software R&D teams, and catalyzing the advancement of an innovative, single-use kidney stone treatment device. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to bring these novel concepts through all phases of development to commercialization.

In this Role You Will:

• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.
• Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.
• Use SolidWorks to create well-defined models, assemblies, and engineering drawings.
• Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding.
• Define qualification strategies for new designs or processes, working in partnership with other teams across the organization to gain alignment.
• Meaningfully translate customer requirements into new or revised product requirements and engineering specifications.
• Drive communication with suppliers to progress activities relevant to component or subassembly development.
• Effectively communicate project progress, results, and risks to relevant stakeholders.
• Develop and validate verification test methods, create and execute protocols, and author associated reports and risk documentation.
• Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines.

Who You Will Report To:

• Director, Instruments Engineering

Requirements:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field, and a minimum of 5 years of medical device experience, OR
• Advanced degree in a related field and a minimum of 4 years of medical device experience
• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.
• Ability to apply DFX principles to create designs that can scale.
• Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T.
• Track record of taking design concepts from prototyping stage through to design maturation.
• Proven design capabilities in injection molding and one or more of the following key areas: electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.
• Experience creating and running simulations (CFD, FEA) to inform product development.
• Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.
• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
• Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.
• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.
• Work location: Pleasanton, CA
• Travel: less than 10%
• Full time employment
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive base salary range of $140,000 - $160,000 and variable incentive plan 
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

Summary:

The Scientist, Scientific Affairs is an integral member of the Medical and Clinical Affairs team and will lead and/or participate in several dynamic workstreams including but not limited to scientific communication strategy, support of clinical and R&D initiatives, regulatory submissions and marketing priorities. The ideal candidate will have a deep understanding of scientific research, clinical development, and market dynamics in the field of urology. This position requires a highly collaborative team member who will work cross-functionally with R&D, regulatory, legal, clinical operations, and marketing. Excellent communication skills and the ability to perform independently in a fast-paced, dynamic environment are essential.

In this role, you will have responsibilities in these areas:

• Scientific Communication
  • Implementation and project management of the company’s scientific podium and publication plan with expected contribution to strategy
  • Creation and timely submission of high-quality peer-reviewed publications, abstracts and presentations covering all categories listed below
  • Build relationships with key opinion leaders (KOLs) to foster research collaborations and ensure timely abstract and publication submissions. In-person support of all KOL presentations at meetings is required
  • Development of deliverables including but not limited to white papers, op eds, and clinical summaries
• Clinical Pipeline Initiatives
  • Collaborate with clinical operations to support trial design, develop protocols, and ensure clinical data supports the company’s scientific objectives
  • Foster communication and alignment with clinical operations and other stakeholders to ensure trial execution is aligned with podium and publication plans. Work cross functionally to adjust timelines if/when milestones may be at risk elevating to leadership as needed
• R&D Projects
  • Support R&D teams and external partners to ensure scientific rigor in the development of preclinical research to clinical trials
  • Project management of the company’s preclinical research strategy, inclusive of adjoining communication plan, with expected contribution to strategy
• Regulatory Submissions
  • Provide medical writing for all FDA submissions
  • Write Clinical Evaluation Reports (CERs); oversee accompanying comprehensive literature review
• Marketing Initiatives
  • Collaborate with the marketing team to translate scientific data into compelling marketing messages and develop scientific content for promotional materials as needed
  • Support medical communications review by ensuring that all marketing materials are scientifically accurate and compliant with regulations
  • Support the scientific analysis of competitive landscape, identifying trends, emerging technologies, and potential threats in the urinary stone market
• Reimbursement and health economic initiatives
  • Project management of the company’s health economics outcomes research strategy, inclusive of adjoining communication plan, with expected contribution to strategy
  • In-depth participation of healthcare claims analyses including benchmark research and vendor identification
  • Continuously liaise with the reimbursement team to ensure clinical pipeline and outcomes meet foreseeable needs; align podium and publication plan accordingly
• Other requirements
  • Attend in-person team building events and contribute meaningfully
  • Attend society meetings as requested to ensure a successful podium plan and seek out immersive research presentations
  • Contribute to a culture of innovation, collaboration and scientific excellence
  • Perform additional activities as assigned by supervisor

Who You Will Report To:

• Manager, Scientific Affairs

Requirements:

• Advanced degree, such as a PhD or MD with proven biostatistical training and application, in a relevant scientific discipline (e.g., Life Sciences, Pharmaceutical Sciences, Clinical Research, or similar fields)
• Minimum of 3.5 to 5 years of experience in scientific affairs, clinical research, or drug development within the pharmaceutical or biotech industry, preferably in urology, nephrology, or related fields
• Strong publication record required with at least 1 first author publication. Please include publication record as part of your resume or CV
• Proven experience in scientific communications, including peer-reviewed publications, abstracts, and scientific presentations
• Demonstrated ability to interact with industry professionals and KOLs
• Experience managing clinical pipelines, regulatory submissions, and R&D projects a plus
• Experience in competitive intelligence and interpreting market trends a plus
• Strong strategic thinking and interpersonal skills with the ability to work in a fast-paced, dynamic start-up environment
• Exceptional written and verbal communication skills, with the ability to translate complex scientific data into clear, concise messaging for diverse audiences
• Ability to work independently with sound autonomous decision making
• Work location: Pleasanton, CA.
• Travel: Up to 25%
• Full-time employment
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which the company complies
• Compliance with relevant county, state, and Federal rules regarding vaccinations

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary range of $120,000 - $140,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:

Calyxo is seeking a Staff Systems Engineer with expertise in fluidic systems to architect, validate, and own the system-level behavior of a complex medical device ecosystem thoughought the entire product development lifecycle.

You will define and own the end-to-end fluidic system architecture, translate user and business needs into robust system and subsystem requirements, validate architectural decisions through prototyping and bench testing, and proactively de‑risk critical technical challenges. This role carries direct accountability for system-level requirements ownership and verification.

The ideal candidate combines hands-on fluidics expertise, strong systems thinking, and the technical leadership expected of a staff-level engineer operating across hardware, software, disposables, and clinical use environments.

In This Role, You Will:

System Architecture & Fluidics Leadership

• Serve as the architect and technical owner of the system with strong focus on the fluidic performance
• Define the end-to-end system architecture encompassing capital equipment, endoscopes, disposable tubing sets, sensors, pumps (positive and negative), and control software.
• Establish and control system interfaces, including fluidic, mechanical, electrical, and software-control boundaries
• Drive architectural trade studies using bench testing, prototyping, and simulation to validate design decisions.
• Ensure architectural robustness across intended use, misuse, fault conditions, and edge cases.

Requirements Ownership & Decomposition

• Own creation, maintenance, and verification of system-level requirements, with particular emphasis on fluidic performance, safety, and reliability.
• Decompose user, clinical, and business needs into clear, testable system and subsystem requirements across:
  • Disposable fluid paths
  • Pumping and flow-control subsystems
  • Sensors and feedback loops
• Ensure complete traceability from user needs through requirements, risks, mitigation, and verification.
• Write requirements that are technically precise, non-prescriptive, and verification-ready.

Risk Reduction & Technical Validation

• Lead identification and mitigation of system-level fluidic risks, including pressure excursions, occlusions, leaks, compliance variability, air management, and failure modes across reusable and disposable components.
• Own or significantly contribute to system-level dFMEAs, ensuring strong linkage between requirements, risk controls, and verification activities.
• Define and support system-level verification strategies, ensuring requirements are objectively testable and clinically relevant.
• Actively de-risk novel or critical aspects of the system through early experimentation and focused learning cycles.

Cross-Functional Technical Leadership

• Serve as the fluidics and systems subject-matter expert across mechanical, electrical, firmware, software, clinical, quality, and product teams.
• Lead architecture reviews, requirements reviews, and system-level design discussions.
• Work closely with other technical leads (mechanical, electrical, and SW) to ensure a fully functional system
• Provide clear technical direction and interface control to external development partners, ensuring alignment with Calyxo’s system architecture and verification strategy.
• Mentor engineers on systems thinking, requirement quality, and architectural rigor.

Who You Will Report To:

• Sr. Manager, Systems and Test Engineering 

Requirements:

Education & Experience

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; Master’s or PhD strongly preferred.
• 12+ years of experience in medical device development, with significant ownership of system architecture.
• Demonstrated expertise in fluidics, including irrigation, aspiration, pressure and flow control, and vacuum systems.
• Strong hands-on experience with both:
  • Single-use disposable systems
  • Capital equipment incorporating pumps, sensors, and closed-loop control

Technical Expertise

• Deep understanding of positive and negative pumping technologies and their control strategies.
• Experience architecting systems that integrate hardware, disposables, and software
• Proven ownership of system-level requirements and verification.
• Proficiency with Jama (or equivalent), dFMEAs, fault-tree analysis, and requirements traceability.
• Strong working knowledge of relevant medical device standards (e.g., ISO 14971, IEC 62304, IEC 60601 family).
• Track record of writing high-quality, testable requirements that scale across complex systems.

Leadership & Communication

• Staff-level technical judgment and decision-making capability.
• Ability to lead through influence and technical authority rather than direct reporting lines.
• Clear, concise technical communicator across disciplines and experience levels.
• Comfortable operating in ambiguity, making informed trade-offs, and driving alignment.

 Work Conditions

• Location: Pleasanton, CA (on-site presence expected 4–5 days per week)
• Travel: Minimal (<10%)

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary if $195,000 - $205,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:  

The Corporate Controller plays a critical role in supporting and advancing our financial reporting within a dynamic, highly regulated medical device environment. This individual will manage day-to-day accounting and drive initiatives related to financial reporting and internal controls. The role involves the preparation of monthly, quarterly and annual financial statements, building and maintaining an effective internal control structure, driving successful external audits, managing cash and other assets, and maintaining comprehensive documentation. The ideal candidate brings extensive public company  experience in a controllership role, ideally from the medical device industry. This is a professional-level role that demands strong technical fluency and the ability to work with accounting managers, staff and external auditors as well as the ability to partner with our executive team and other departments to provide excellent financial information that will influence business decisions and improve financial results. 

In This Role, You Will: 

• Lead Calyxo’s Accounting Function: Manage a team of seven to provide full accounting support to the organization, including managing day-to-day activities, Timely and accurate preparation of monthly, quarterly and annual financial statements in accordance with US GAAP, completion of external audits, and payroll and tax reporting. 
• Drive efficient monthly accounting closes: Complete monthly, quarterly and annual accounting closes, financial statement preparation, audit preparation and internal controls testing within timelines that would support SEC public reporting, including reviews of journal entries and account reconciliations. 
• Own Revenue Recognition: Partner with Finance to timely track sales including rebates and GPO fees and ensure revenue is properly recognized per US GAAP. 
• Manage cost accounting: Deeply understand cost drivers in our products and drive sustained margin improvement and comprehensive cost reporting. Strong knowledge of cost accounting and experience supporting both internal and contract manufacturing environments is a must. 
• Treasury and Risk Management: Work with VP Accounting on short-term investments to manage yield and preservation of capital and annual insurance renewals.  Ensure compliance with debt and equity quarterly information  requirements. 
• Tax: Ensures compliance with local, state, and Federal statutory tax requirements; timely providing outside tax preparers with accounting information for income tax provisions and tax returns and managing sales tax reporting using Avalara. 
• Regulatory Compliance: Manage accounting areas including expense reports to ensure compliance with regulatory reporting requirements such as the Physician Payments Sunshine Act. 
• Processes and Systems: Drive exponential improvements in systems and processes to keep pace with the growth of the company and work cross-functionally to implement them. 
• Internal Controls: Protects assets and ensure effective financial reporting by establishing, monitoring, and enforcing internal controls. 
• People: Drive the accounting team’s job results by coaching, counseling, planning, monitoring, and appraising job results.  Crosstrain and continuously develop team to increase flexibility and capacity. 
• Equity Reporting: Maintain quarterly stock option processing, stock compensation expense accounting and equity reporting within Carta or other equity software. 
• Performs other related duties as assigned by Manager.

Who You Are: 

• 10-15+ years of high-growth accounting experience, with at least 5 years demonstrated experience in a controllership role. You've previously helped build and scale accounting functions at fast growing medical device companies (or other FDA regulated environments) as they dramatically expand commercialization or become public. Controllership experience in a public company subject to SOX 404A is preferred, along with the ability to continuously deliver high quality quarterly financial statements, audit packages and 10K/Q reporting each quarter.   
• You are a great "player-coach" and project manager, able to dive into the weeds and own it or delegate effectively as needed to meet reporting timelines.  
• Strong expertise in Accounting systems and internal controls. You get the books closed quickly and accurately and build high quality management reporting with ease. You’re deeply knowledgeable about US GAAP and audit best practices and have advanced proficiency in building internal controls structures compliant with SOX 404A and the COSO Internal Control—Integrated Framework.  
• You’re great at balancing strategic thinking and details. You are at home thinking big and helping manage the strategic drivers, while diving into the details and spending the time to make sure your output is stellar. You have a good sense of where to focus to maximize your productivity vs. the time investment required. 
• A growth mindset and comfort with ambiguity. You are comfortable working in a dynamically growing commercial environment that will require you to build systems and processes while effectively managing the day-to-day competing priorities to support our customers and executive team. 
• Excellent communication and partnership skills. You can effectively engage with all of our stakeholders to earn their trust in you as a strategic partner while asking the right questions and pushing the team appropriately to maximize our growth. Excellent written and verbal communication skills are a must. 
• A team player. You bring a positive energy to your teams and are generally known for being great to work with. 

Who You Will Report To: 

•   Vice President, Accounting

Additional Requirements: 

• Strong knowledge of accounting systems, including NetSuite, Salesforce, Avalara, Concur, Carta and others. 
• Bachelor’s degree in Accounting, Finance, or related field required; CPA or Masters in Accounting strongly preferred. 
• Experience with the regulated environments including FDA regulations and HCP (Sunshine Act) reporting requirements strongly preferred. 
• Experience in an S-1 registration process is a plus. 
• Significant experience in U.S. taxes, including Federal and multistate income taxes, sales taxes and property taxes. 
• Ability to manage sensitive information with discretion and ensure alignment with corporate and regulatory standards. 
• Work Location: Pleasanton (hybrid schedule between work-from-home and headquarters; minimum 3 days per week in Pleasanton headquarters) 
• Travel: Approximately 5%. 
• Must be able to sit for up to 8 hours/day. 

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

We also offer an attractive compensation package, which includes: 

• A competitive base salary range of $250,000 - $270,000 and variable incentive plan  
• Stock options – ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation 

Summary:

The Senior R&D Technician is a critical member of the Instruments team, responsible for hands-on support in the design, testing, and manufacturing of innovative medical devices. This role blends technical skill with collaboration, playing a vital part in building and evaluating prototypes, improving processes, and maintaining equipment to ensure high-quality and regulatory-compliant products. Working closely with R&D, engineering, and manufacturing teams, the Senior Technician contributes to key milestones from early-stage development through product launch and beyond in a dynamic, fast-paced medical device environment.

In This Role, You Will:

• Support product development by building prototypes, conducting tests, and documenting results in collaboration with R&D and engineering teams.
• Support process development through hands-on prototyping and problem solving.
• Perform root cause analysis of technical issues and recommend corrective actions.
• Maintain lab equipment, fixtures, and tools to ensure consistent performance.
• Assist in validation activities including IQ/OQ/PQ and design verification testing.
• Support manufacturing transfer activities including pilot builds and process documentation.
• Ensure compliance with company quality systems (e.g., ISO 13485, FDA 21 CFR Part 820).

Who You Will Report To:

• Director, Instruments Engineering

Requirements:

• Education: Associates degree or technical certification in biomedical engineering, mechanical engineering or related field
• Minimum 5 years experience in a medical device, biotech or other related regulated field
• Competent with hands on prototyping and basic shop tools (test machines, hand tools, machining tools, soldering etc)
• Experience with catheter build and construction techniques (laminating, tipping, joining, braiding, laser cutting) highly desirable
• Experience with 3-D printing highly desirable
• Working knowledge of computers, word processing, Good Documentation Practices (GDP) and spreadsheets
• Competent in reading and understanding engineering drawings and specifications to accurately assemble and build prototypes
• Work location: Pleasanton, CA. This job is fully on-site
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Preferred Qualifications:

• Solidworks or other CAD software

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive hourly rate range of $40.86 - $45.67 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary: 

The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment. 

The Clinical Specialist will train the surgical team on instrument preparation prior to cases and during the surgical procedure. This role will manage inventory needs in the account and any accompanying administrative requirements.  

This role is not considered for pathway to a Territory Sales Manager at Calyxo Inc, due to the tenure and experience required to execute the Territory Sales Manager role. 

Ideal candidates will live in the targeted geographical area.  

This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales training programs. 

In This Role, You Will: 

• Provide clinical case coverage as assigned 
• Train the surgical team to assist in good patient outcomes and verbally support cases during training period 
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital policies and procedures 
• Develop technical acumen to a level to serve as an educational resource 
• Demonstrate appropriate interactions with all hospital service providers 
• Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits 
• Troubleshoot equipment according to standard procedure 
• Provide intra-operative clinical product support 
• Ensure that 100% of received inventory and returned inventory matches shipping documents 
• Reconcile inventory/usage as well as missing inventory 
• Assist in the delivery of procedural training to physicians and medical staff 
• Be an effective member of the commercial team and play a key role in ensuring positive clinical outcomes 
• In partnership with TSM, perform account management: such as Account Set Up, Clinical Engagement, Case Support and Clinical Outcomes  
• In Partnership with TSM, support education of APPs, Office and Hospital Staff 
• In partnership with TSM, help facilitate and support Residency Education 
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with health care professionals 
• In this role, you will collaborate with Clinical Specialist teams to review and discuss case presentations and peer to peer knowledge sharing 
• Other duties as assigned 

 Who You Will Report To: 

•  Regional Clinical Manager (RCM) 

 Clinical Specialist I Requirements: 

• Clinical experience such as: 
  • Scrub Tech 
  • X-Ray Tech 
  • RN or BSN 
  • Laser Tech 

Clinical Specialist II Requirements: 

• In addition to all of the above: 
• Industry experience (1-3 years) 
• Prior Employment as a Clinical Specialist with a medical device company or experience working with Mobile Litho Provider Companies 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Willingness to travel outside of the designated territory 

Sr. Clinical Specialist Requirements: 

• In addition to all of the above 
• Industry experience: 3+ years of full-time employment by a medical device company as a clinical specialist (or comparable position) focused on case coverage and patient outcomes (not equipment/service provider). 
• Clinical experience: Intraoperative Coaching Experience 
• OR experience: Fluent in Staff and Support Training 
• Track record of success. Urology experience preferred. 
• Understands the medical device industry 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Understands sales processes and training 
• Willingness to travel outside of the designated territory  

General Requirements:  

• Experience in surgical technique and sterile procedures in the operating room 
• Experience utilizing fluoroscopy is a plus 
• Customer relationship and procedural skill development are highly desired 
• Highly desirable candidates will have a degree or certification in a medical-related field (ex: LPN, RN, Surg Tech, Rad Tech, etc). 
• Able to travel by car up to 90% 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary
  • Total Compensation: $100,000 - $140,000 annually
    • Base Salary: $80,000, $100,000, or $120,000 per year (DOE)
    • Annual Variable Bonus: $20,000
  • Plus, generous allowances such as:
    • Auto Allowance: $9,600
    • Cell Phone/Internet Allowance: $1,800
• Stock options: ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary: 

The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment. 

The Clinical Specialist will train the surgical team on instrument preparation prior to cases and during the surgical procedure. This role will manage inventory needs in the account and any accompanying administrative requirements.  

This role is not considered for pathway to a Territory Sales Manager at Calyxo Inc, due to the tenure and experience required to execute the Territory Sales Manager role. 

Ideal candidates will live in the targeted geographical area.  

This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales training programs. 

In This Role, You Will: 

• Provide clinical case coverage as assigned 
• Train the surgical team to assist in good patient outcomes and verbally support cases during training period 
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital policies and procedures 
• Develop technical acumen to a level to serve as an educational resource 
• Demonstrate appropriate interactions with all hospital service providers 
• Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits 
• Troubleshoot equipment according to standard procedure 
• Provide intra-operative clinical product support 
• Ensure that 100% of received inventory and returned inventory matches shipping documents 
• Reconcile inventory/usage as well as missing inventory 
• Assist in the delivery of procedural training to physicians and medical staff 
• Be an effective member of the commercial team and play a key role in ensuring positive clinical outcomes 
• In partnership with TSM, perform account management: such as Account Set Up, Clinical Engagement, Case Support and Clinical Outcomes  
• In Partnership with TSM, support education of APPs, Office and Hospital Staff 
• In partnership with TSM, help facilitate and support Residency Education 
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with health care professionals 
• In this role, you will collaborate with Clinical Specialist teams to review and discuss case presentations and peer to peer knowledge sharing 
• Other duties as assigned 

 Who You Will Report To: 

•  Regional Clinical Manager (RCM) 

 Clinical Specialist I Requirements: 

• Clinical experience such as: 
  • Scrub Tech 
  • X-Ray Tech 
  • RN or BSN 
  • Laser Tech 

Clinical Specialist II Requirements: 

• In addition to all of the above: 
• Industry experience (1-3 years) 
• Prior Employment as a Clinical Specialist with a medical device company or experience working with Mobile Litho Provider Companies 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Willingness to travel outside of the designated territory 

Sr. Clinical Specialist Requirements: 

• In addition to all of the above 
• Industry experience: 3+ years of full-time employment by a medical device company as a clinical specialist (or comparable position) focused on case coverage and patient outcomes (not equipment/service provider). 
• Clinical experience: Intraoperative Coaching Experience 
• OR experience: Fluent in Staff and Support Training 
• Track record of success. Urology experience preferred. 
• Understands the medical device industry 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Understands sales processes and training 
• Willingness to travel outside of the designated territory  

General Requirements:  

• Experience in surgical technique and sterile procedures in the operating room 
• Experience utilizing fluoroscopy is a plus 
• Customer relationship and procedural skill development are highly desired 
• Highly desirable candidates will have a degree or certification in a medical-related field (ex: LPN, RN, Surg Tech, Rad Tech, etc). 
• Able to travel by car up to 90% 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary
  • Total Compensation: $100,000 - $140,000 annually
    • Base Salary: $80,000, $100,000, or $120,000 per year (DOE)
    • Annual Variable Bonus: $20,000
  • Plus, generous allowances such as:
    • Auto Allowance: $9,600
    • Cell Phone/Internet Allowance: $1,800
• Stock options: ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary: 

The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment. 

The Clinical Specialist will train the surgical team on instrument preparation prior to cases and during the surgical procedure. This role will manage inventory needs in the account and any accompanying administrative requirements.  

This role is not considered for pathway to a Territory Sales Manager at Calyxo Inc, due to the tenure and experience required to execute the Territory Sales Manager role. 

Ideal candidates will live in the targeted geographical area.  

This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales training programs. 

In This Role, You Will: 

• Provide clinical case coverage as assigned 
• Train the surgical team to assist in good patient outcomes and verbally support cases during training period 
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital policies and procedures 
• Develop technical acumen to a level to serve as an educational resource 
• Demonstrate appropriate interactions with all hospital service providers 
• Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits 
• Troubleshoot equipment according to standard procedure 
• Provide intra-operative clinical product support 
• Ensure that 100% of received inventory and returned inventory matches shipping documents 
• Reconcile inventory/usage as well as missing inventory 
• Assist in the delivery of procedural training to physicians and medical staff 
• Be an effective member of the commercial team and play a key role in ensuring positive clinical outcomes 
• In partnership with TSM, perform account management: such as Account Set Up, Clinical Engagement, Case Support and Clinical Outcomes  
• In Partnership with TSM, support education of APPs, Office and Hospital Staff 
• In partnership with TSM, help facilitate and support Residency Education 
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with health care professionals 
• In this role, you will collaborate with Clinical Specialist teams to review and discuss case presentations and peer to peer knowledge sharing 
• Other duties as assigned 

 Who You Will Report To: 

•  Regional Clinical Manager (RCM) 

 Clinical Specialist I Requirements: 

• Clinical experience such as: 
  • Scrub Tech 
  • X-Ray Tech 
  • RN or BSN 
  • Laser Tech 

Clinical Specialist II Requirements: 

• In addition to all of the above: 
• Industry experience (1-3 years) 
• Prior Employment as a Clinical Specialist with a medical device company or experience working with Mobile Litho Provider Companies 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Willingness to travel outside of the designated territory 

Sr. Clinical Specialist Requirements: 

• In addition to all of the above 
• Industry experience: 3+ years of full-time employment by a medical device company as a clinical specialist (or comparable position) focused on case coverage and patient outcomes (not equipment/service provider). 
• Clinical experience: Intraoperative Coaching Experience 
• OR experience: Fluent in Staff and Support Training 
• Track record of success. Urology experience preferred. 
• Understands the medical device industry 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Understands sales processes and training 
• Willingness to travel outside of the designated territory  

General Requirements:  

• Experience in surgical technique and sterile procedures in the operating room 
• Experience utilizing fluoroscopy is a plus 
• Customer relationship and procedural skill development are highly desired 
• Highly desirable candidates will have a degree or certification in a medical-related field (ex: LPN, RN, Surg Tech, Rad Tech, etc). 
• Able to travel by car up to 90% 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary
  • Total Compensation: $100,000 - $140,000 annually
    • Base Salary: $80,000, $100,000, or $120,000 per year (DOE)
    • Annual Variable Bonus: $20,000
  • Plus, generous allowances such as:
    • Auto Allowance: $9,600
    • Cell Phone/Internet Allowance: $1,800
• Stock options: ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary: 

The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment. 

The Clinical Specialist will train the surgical team on instrument preparation prior to cases and during the surgical procedure. This role will manage inventory needs in the account and any accompanying administrative requirements.  

This role is not considered for pathway to a Territory Sales Manager at Calyxo Inc, due to the tenure and experience required to execute the Territory Sales Manager role. 

Ideal candidates will live in the targeted geographical area.  

This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales training programs. 

In This Role, You Will: 

• Provide clinical case coverage as assigned 
• Train the surgical team to assist in good patient outcomes and verbally support cases during training period 
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital policies and procedures 
• Develop technical acumen to a level to serve as an educational resource 
• Demonstrate appropriate interactions with all hospital service providers 
• Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits 
• Troubleshoot equipment according to standard procedure 
• Provide intra-operative clinical product support 
• Ensure that 100% of received inventory and returned inventory matches shipping documents 
• Reconcile inventory/usage as well as missing inventory 
• Assist in the delivery of procedural training to physicians and medical staff 
• Be an effective member of the commercial team and play a key role in ensuring positive clinical outcomes 
• In partnership with TSM, perform account management: such as Account Set Up, Clinical Engagement, Case Support and Clinical Outcomes  
• In Partnership with TSM, support education of APPs, Office and Hospital Staff 
• In partnership with TSM, help facilitate and support Residency Education 
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with health care professionals 
• In this role, you will collaborate with Clinical Specialist teams to review and discuss case presentations and peer to peer knowledge sharing 
• Other duties as assigned 

 Who You Will Report To: 

•  Regional Clinical Manager (RCM) 

 Clinical Specialist I Requirements: 

• Clinical experience such as: 
  • Scrub Tech 
  • X-Ray Tech 
  • RN or BSN 
  • Laser Tech 

Clinical Specialist II Requirements: 

• In addition to all of the above: 
• Industry experience (1-3 years) 
• Prior Employment as a Clinical Specialist with a medical device company or experience working with Mobile Litho Provider Companies 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Willingness to travel outside of the designated territory 

Sr. Clinical Specialist Requirements: 

• In addition to all of the above 
• Industry experience: 3+ years of full-time employment by a medical device company as a clinical specialist (or comparable position) focused on case coverage and patient outcomes (not equipment/service provider). 
• Clinical experience: Intraoperative Coaching Experience 
• OR experience: Fluent in Staff and Support Training 
• Track record of success. Urology experience preferred. 
• Understands the medical device industry 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Understands sales processes and training 
• Willingness to travel outside of the designated territory  

General Requirements:  

• Experience in surgical technique and sterile procedures in the operating room 
• Experience utilizing fluoroscopy is a plus 
• Customer relationship and procedural skill development are highly desired 
• Highly desirable candidates will have a degree or certification in a medical-related field (ex: LPN, RN, Surg Tech, Rad Tech, etc). 
• Able to travel by car up to 90% 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary
  • Total Compensation: $100,000 - $140,000 annually
    • Base Salary: $80,000, $100,000, or $120,000 per year (DOE)
    • Annual Variable Bonus: $20,000
  • Plus, generous allowances such as:
    • Auto Allowance: $9,600
    • Cell Phone/Internet Allowance: $1,800
• Stock options: ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary: 

The Clinical Specialist is a focused individual who has a passion for patient care and physician and staff education. This person will proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device. The Clinical Specialist works closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment. 

The Clinical Specialist will train the surgical team on instrument preparation prior to cases and during the surgical procedure. This role will manage inventory needs in the account and any accompanying administrative requirements.  

This role is not considered for pathway to a Territory Sales Manager at Calyxo Inc, due to the tenure and experience required to execute the Territory Sales Manager role. 

Ideal candidates will live in the targeted geographical area.  

This position can cover any CVAC case in the territory, region, or at times, the nation, as assigned. The Clinical Specialist will also provide clinical support for physician training and sales training programs. 

In This Role, You Will: 

• Provide clinical case coverage as assigned 
• Train the surgical team to assist in good patient outcomes and verbally support cases during training period 
• Acquire and maintain current knowledge of perioperative surgical technology practice and hospital policies and procedures 
• Develop technical acumen to a level to serve as an educational resource 
• Demonstrate appropriate interactions with all hospital service providers 
• Maintain and prepare equipment and kits for surgery, including Quality Control audits of equipment and kits 
• Troubleshoot equipment according to standard procedure 
• Provide intra-operative clinical product support 
• Ensure that 100% of received inventory and returned inventory matches shipping documents 
• Reconcile inventory/usage as well as missing inventory 
• Assist in the delivery of procedural training to physicians and medical staff 
• Be an effective member of the commercial team and play a key role in ensuring positive clinical outcomes 
• In partnership with TSM, perform account management: such as Account Set Up, Clinical Engagement, Case Support and Clinical Outcomes  
• In Partnership with TSM, support education of APPs, Office and Hospital Staff 
• In partnership with TSM, help facilitate and support Residency Education 
• Ensure compliance with all company policies, including the quality policy, on label promotion and interactions with health care professionals 
• In this role, you will collaborate with Clinical Specialist teams to review and discuss case presentations and peer to peer knowledge sharing 
• Other duties as assigned 

 Who You Will Report To: 

•  Regional Clinical Manager (RCM) 

 Clinical Specialist I Requirements: 

• Clinical experience such as: 
  • Scrub Tech 
  • X-Ray Tech 
  • RN or BSN 
  • Laser Tech 

Clinical Specialist II Requirements: 

• In addition to all of the above: 
• Industry experience (1-3 years) 
• Prior Employment as a Clinical Specialist with a medical device company or experience working with Mobile Litho Provider Companies 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Willingness to travel outside of the designated territory 

Sr. Clinical Specialist Requirements: 

• In addition to all of the above 
• Industry experience: 3+ years of full-time employment by a medical device company as a clinical specialist (or comparable position) focused on case coverage and patient outcomes (not equipment/service provider). 
• Clinical experience: Intraoperative Coaching Experience 
• OR experience: Fluent in Staff and Support Training 
• Track record of success. Urology experience preferred. 
• Understands the medical device industry 
• Comfortable with the pace required to be successful in a start-up 
• Ability to provide intraoperative procedural guidance 
• Understands sales processes and training 
• Willingness to travel outside of the designated territory  

General Requirements:  

• Experience in surgical technique and sterile procedures in the operating room 
• Experience utilizing fluoroscopy is a plus 
• Customer relationship and procedural skill development are highly desired 
• Highly desirable candidates will have a degree or certification in a medical-related field (ex: LPN, RN, Surg Tech, Rad Tech, etc). 
• Able to travel by car up to 90% 
• Compliance with relevant county, state, and federal rules regarding vaccinations. 

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary
  • Total Compensation: $100,000 - $140,000 annually
    • Base Salary: $80,000, $100,000, or $120,000 per year (DOE)
    • Annual Variable Bonus: $20,000
  • Plus, generous allowances such as:
    • Auto Allowance: $9,600
    • Cell Phone/Internet Allowance: $1,800
• Stock options: ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:

The Senior Manager, Sourcing and Procurement, role leads a team that oversees Calyxo’s Sourcing and Procurement department.  Functional responsibility includes Strategic Sourcing and Category Management, Procurement, and Supplier Management.  This team will partner closely with New Product teams to develop supplier partnerships for new products, as well as Sustaining teams to optimize our current supplier network.   This leader will work closely with Calyxo leadership to develop the strategy vision to build robust capabilities and year over year improvements to our key Supply Chain enablers: Supply Quality, Supply Assurance, Cost Management, and Scalability.

In This Role, You Will:

• Lead the Sourcing and Procurement Department for Calyxo. Scope includes all enterprise-wide supplier spend
• Develop and own department 3-5 year strategic roadmap to improve processes and systems related to Sourcing and Procurement functions; supporting company in high double digit growth mode
• Supply Chain primary point of contact for New Product Development portfolio. Collaborate with R&D, Product, Engineering, and Commercial teams on Supply Chain and overall project deliverables from Concept to Launch
• Develop category strategies to address cost, quality, risk mitigation, and scale opportunities across all spend categories, with near term focus on Direct Categories (materials, freight, contract manufacturing)
• Lead all Sourcing activities (Conduct Supply Market Analysis, ID and Select candidate suppliers, run Competitive selections/Direct negotiations, negotiate and award) in support of category strategies and business priorities
• Own Supplier Governance, working closely with Supplier Quality team
• Work closely with S&OP team to ensure material availability and supplier readiness
• Develop and manage a supplier risk mitigation program
• Lead direct report(s), support onboarding, skill development, and role effectiveness through regular check‑ins, feedback, and coaching.

Who You Will Report To:

• See organizational chart

Requirements:

• 8-10 years of relevant sourcing / procurement experience in a Medical Device industry REQUIRED
• Demonstrated ability to coach, mentor, and collaborate effectively, with strong interpersonal skills and a thoughtful approach to supporting individual performance, development, and engagement of team members.
• Proven experience managing a Direct Spend category such as raw materials and components; indirect spend experience a strong plus
• Experience working with Contract and/or Toll Manufacturing partners; internal manufacturing experience a plus
• Catheter based medical device experience a strong plus
• Strong project management skills
• Experience with strategic planning, setting vision, and executing multi-year transformational programs
• Self-starter, demonstrated ability operate and excel in ill-defined environments requiring structure
• Excellent business partner engagement skills, influencing will be a key component of this role
• Ability to navigate through a matrixed organization
• Global experience a plus

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary range of $170,000 - $190,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Summary:  

The Sr. Director, Financial Planning & Analysis (FP&A) plays a pivotal role in shaping the company’s financial strategy, driving enterprise-wide performance, and supporting executive decision-making in a fast-growing medical device organization. This role serves as a key strategic partner to the VP Finance, CFO and executive leadership team, leading financial planning, forecasting, and long-range strategy while providing actionable insights that influence the direction of the business. 

The Sr. Director will own enterprise financial planning processes, enhance financial infrastructure to support scale, and lead high-impact strategic initiatives including capital allocation, investment prioritization, and potential IPO readiness. The ideal candidate brings deep financial expertise, executive presence, and a proven track record of leading finance functions in dynamic, high-growth environments. 

In This Role, You Will 

Enterprise Financial Planning Leadership 

• Partner with the VP of Finance and CFO to lead and evolve enterprise-wide financial planning across P&L, Balance Sheet, and Cash Flow, driving improved forecast accuracy, financial visibility, and operational alignment. 
• Own and lead key planning cycles including: 
• Annual Operating Plan (AOP): Enterprise-wide budget across revenue, operating expenses, headcount, and capital expenditures 
• Quarterly Forecasting: Rolling 12–18 month outlook with executive-level insights and risk/opportunity identification 
• Long-Range Planning (LRP): 3–5 year strategic financial plans incorporating scenario modeling, capital strategy, and growth initiatives 
• Establish scalable planning processes and frameworks to support rapid organizational growth and increased complexity 

Executive Reporting & Strategic Insights 

• Own executive and Board-level financial reporting, including dashboards, KPI frameworks, variance analysis, and Board of Directors materials 
• Provide forward-looking insights and recommendations that directly influence executive decision-making and company strategy 
• Synthesize complex financial and operational data into clear, actionable narratives for senior leadership and investors 

Strategic Business Partnership 

• Serve as a senior finance partner to executive leadership across Sales, R&D, Clinical, Market Access, Quality & Regulatory, Operations, Marketing, and G&A 
• Provide financial leadership for: 
• Product launches, clinical trials, and commercialization strategies 
  Market expansion, pricing strategy, and reimbursement dynamics 
• Resource allocation and capital investment decisions 
• Influence strategic decisions including portfolio prioritization, go-to-market strategies, and long-term growth initiatives 

Financial Close & Reporting Alignment 

• Provide oversight and alignment with Accounting during monthly and quarterly close processes to ensure accurate, timely, and consistent financial reporting 
• Ensure strong linkage between actuals, forecasts, and strategic plans across all functions 

Advanced Financial Modeling & Decision Support 

• Oversee development of sophisticated financial models supporting: 
• Capital allocation and investment decisions 
• ROI and profitability analysis 
• Scenario planning and sensitivity analysis 
• Strategic and inorganic growth initiatives 
• Provide financial leadership on M&A, partnerships, and strategic investments 

Systems, Process & Data Transformation 

• Lead transformation and optimization of financial planning systems, tools, and processes (e.g., Adaptive Insights, NetSuite, Tableau) 
• Drive automation, scalability, and data governance to enhance decision-making capabilities 
• Build a best-in-class FP&A infrastructure to support future public company readiness 

Governance, Compliance & IPO Readiness 

• Ensure adherence to internal controls and regulatory requirements including GAAP, SEC, and IRS standards 
• Partner with executive leadership to support IPO readiness, including financial reporting rigor, controls enhancement, and investor readiness 
• Support internal and external audits and maintain strong governance in a regulated medical device environment 

Leadership & Organizational Development 

• Build, lead, and mentor a high-performing FP&A team, fostering a culture of accountability, strategic thinking, and continuous improvement 
• Lead enterprise-wide financial initiatives and influence outcomes at the executive and Board level 
• Act as a trusted advisor to senior leadership, contributing to overall business strategy beyond finance 

Additional Responsibilities 

• Perform other duties as assigned 

Who You Will Report To: 

•  Vice President, Finance 

Qualifications 

• 18+ years of progressive finance experience, including significant leadership in FP&A, corporate finance, and strategic planning 
• 5+ years of experience in medical devices, healthcare, life sciences, or other regulated industries.
• Bachelor’s degree in Finance, Accounting, Economics, or related field required; MBA and/or CPA strongly preferred 
• Deep expertise in financial planning, investment analysis, capital allocation, long-range planning (LRP), and scenario modeling 
• Proven ability to influence executive leadership and drive strategic decision-making in a high-growth environment 
• Demonstrated success partnering with C-level executives and cross-functional leaders across Commercial, R&D, Clinical, Operations, and Supply Chain 
• Extensive experience preparing and presenting Board of Directors and investor materials 
• Strong background in commercial finance including revenue forecasting, pricing strategy, and sales performance optimization 
• Expertise in margin analysis, reimbursement dynamics, and profitability optimization across products and markets 
• Experience supporting product development, clinical investment planning, and commercialization strategies 
• Strong operational finance acumen including supply chain, inventory, and cost management 
• Experience with M&A evaluation and strategic investments, including financial modeling, due diligence, and integration support 
• Experience supporting IPO readiness initiatives, including public-company financial modeling, reporting controls, S-1 preparation, and investor communications 
• Proven ability to lead large, complex cross-functional initiatives in a fast-paced, high-growth environment 
• Advanced proficiency in Excel and experience with enterprise systems such as Adaptive Insights, NetSuite, Tableau, and Salesforce 
• Exceptional executive communication and presentation skills, with the ability to influence both financial and non-financial stakeholders 
• Work location:  Pleasanton  
• Travel:  5-10% 
• Full time employment 
• Ability to thrive in a fast-paced, dynamic environment. 
• Must be able to lift 10 pounds, sit for up to 8 hours/day 
• Compliance with relevant county, state, and Federal rules regarding vaccinations. 

What We Offer: 

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.   

We also offer an attractive compensation package, which includes: 

• A competitive base salary range of $250,000 - $270,000 and variable incentive plan  
• Stock options – ownership and a stake in growing a mission-driven company 
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation 

Summary:  

The Marketing Communications Manager supports the development and execution of integrated marketing communications that drive awareness, education, and engagement across both healthcare professionals and patients throughout the kidney stone care journey. This role is ideal for a hands-on marketer who thrives in a fast-paced environment, enjoys collaborating across teams, and is passionate about translating complex clinical information into clear and compelling communications. 

This individual will help execute a range of HCP and patient-facing marketing initiatives, including educational programs, digital campaigns, content development, and sales enablement tools that support adoption of Calyxo technologies and improve the patient experience. 

Key Responsibilities 

Marketing Communications and Campaign Execution 

• Support the development and execution of integrated marketing communications across healthcare professional and patient audiences. 

• Assist in the planning and rollout of digital campaigns, product communications, and educational initiatives that support brand awareness and technology adoption. 

• Coordinate the development of marketing materials including web content, social media assets, email campaigns, videos, presentations, and print collateral. 

• Partner with internal teams to ensure communications are consistent with brand standards, compliant with regulatory requirements, and aligned with commercial strategy. 

• Collaborate with and help manage external marketing agencies, creative partners, and vendors supporting campaign execution. 

Patient Marketing and Education 

• Support the development and execution of patient education and engagement programs, including joint education initiatives, digital campaigns, and practice-level outreach tools. 

• Help develop and manage patient communication journeys (email, in-office materials, digital touchpoints) aligned to key patient milestones. 

• Lead the development of patient-facing educational materials, including print and digital materials, videos, social media content, and FAQs, 

• Identify common patient questions and barriers to care and support the development of content that improves patient understanding and engagement. 

• Work with medical, clinical, legal, and quality/regulatory teams to ensure patient communications are accurate, compliant, and accessible. 

Healthcare Professional (HCP) Marketing Communications 

• Support the development of physician education materials, sales enablement tools, and promotional content used by the commercial organization. 

• Assist with marketing support for conferences, physician training programs, and educational initiatives. 

• Contribute to the development and maintenance of presentations, brochures, digital assets, and other materials used by the field team. 

Program Coordination and Lifecycle Management 

• Help manage project timelines, deliverables, and workflows across marketing initiatives. 

• Assist in documenting best practices and creating repeatable tools and templates for marketing programs. 

Measurement and Reporting 

• Track and report on key metrics across marketing programs, including engagement, campaign performance, and program adoption. 

• Support data analysis and reporting to evaluate program effectiveness and identify optimization opportunities. 

• Compile insights and recommendations to inform future marketing strategies and campaigns. 

Who You Will Report To: 

•   Senior Manager, Marketing Communications

Requirements: 

• 5-7 years of experience in marketing or marketing communications in the medical device, healthcare, or life sciences industries 

• Bachelor’s degree in marketing, business administration, communications, or a related field (or equivalent experience) 

• Experience supporting HCP marketing, patient education, or healthcare communications initiatives 

• Ability to work in a fast-paced, high-growth environment 

• Proficiency with marketing, design, and productivity tools, including Microsoft Office, Adobe Creative Suite, Canva, and other platforms used to develop presentations, digital assets, and marketing materials. 

• Excellent communication and interpersonal skills with the ability to collaborate effectively across teams 

• Strong attention to detail and project management skills 

• Experience working with external agencies or creative vendors 

• Knowledge of regulatory requirements and compliance standards for medical devices or healthcare marketing