Follows guidance from the senior leader to deliver and implement customer training and support. Performs virtual and onsite visits for imaging site support. Denver, Los Angeles, or Dallas based. 

Responsibilities

• Communicates with imaging partners to increase efficiency and quality of performed scans through education of CCTA best practices for: patient preparation, acquisition, reconstruction, and heart rate control;
• Performs virtual and onsite support events with our imaging partners;
• Organizes and leads training events
• Attends or reviews recording/AI Companion notes for all assigned meetings;
• Reports and documents all related concerns and recommended process improvements to imaging sites and leadership;
• Demonstrates Cleerly software;
• Collaborates with other departments and CT vendors to standardize best practices for image quality and workflow efficiency.
• In person (25% - 50% required travel);
• Travel within the US and International;
• In virtual meetings (50% - 75%);

Required Competencies

• ARRT (CT) required;
• Minimum level of education is an associate degree in radiologic technology or equivalent;
• 2+ years Coronary CTA experience;
• Basic Computer Software Knowledge.

Soft Skills            

• Communication: Clear, concise communication to convey plans and initiatives to team members and stakeholders;
• Critical thinking: evaluate various planning scenarios, anticipate challenges;
• Adaptability: adjust plans in response to unexpected developments;
• Coachability - willingness to Learn;
• Collaboration: cross-functional projects;

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 10% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $103,000 - $108,000
• TTC: $113,300 - $118,800

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Team

The Quality and Regulatory team at Cleerly has the mission to empower team members to bring new, safe, and effective products to market and implement a quality foundation to support a patient-focused, innovative heart care organization.

About the Opportunity

The Principal Design Quality Engineer will be expected to contribute to maintaining the safety and efficacy of Cleerly’s software medical device products. You will be a key member of the product development team, ensuring that our software medical devices are developed in compliance with our ISO 13485 certified Quality Management System and applicable standards and regulations.

Responsibilities

• Act as the design quality engineering lead on software development project teams, providing guidance and oversight to ensure compliance with the Quality Management System (QMS) and external regulations.
• Review and approve design and development documentation, including user needs, requirements specifications, software architecture, and verification & validation (V&V) plans, protocols, and reports.
• Ensure all design control activities are compliant with ISO 13485, IEC 62304, and FDA 21 CFR Part 820.
• Facilitate, document, and maintain risk management activities according to ISO 14971 throughout the product lifecycle, from initial concept through post-market surveillance.
• Collaborate with engineering teams to ensure test methodologies are robust, effective, and well-documented for verifying and validating the software medical device.
• Maintain the Design History File (DHF) for assigned projects, ensuring they are complete, accurate, and ready for audits and regulatory inspections.
• Provide quality oversight for the software development lifecycle (SDLC) within an agile development environment, ensuring quality is built into the process.
• Participate in design reviews, technical reviews, and other project meetings to ensure quality considerations are addressed and integrated.
• Participate in software issue triage to determine risk of issues to the medical device and aid in development prioritization.
• Support the investigation of design-related complaints and contribute to Corrective and Preventive Action (CAPA) activities as required.
• Team leader who, in conjunction with management, designs and drives team-wide and company-wide training in the above areas. 

Requirements

• Bachelor’s degree in engineering, computer science, or a related engineering discipline.
• 12+ years of experience in a Design Quality or Quality Engineering role within the medical device industry, with a strong focus on software as a medical device (SaMD).
• Excellent analytical and problem-solving skills with a high degree of attention to detail.
• In-depth, practical knowledge of ISO 13485, with extensive experience in Product Realization processes.
• Proven experience applying IEC 62304 (Medical device software - software life cycle processes) and ISO 14971 (Application of risk management to medical devices).
• Strong understanding of FDA Quality System Regulation (21 CFR Part 820) and familiarity with other global medical device regulations (e.g., EU MDR).
• Hands-on experience with modern software development and testing tools such as GitHub for source control, TestRail for test case management, and CI/CD pipelines.
• Strong written and verbal communication skills, with the ability to work effectively in cross-functional, remote teams.
• ASQ certification (e.g., CSQE, CQE) is a plus.
• Travel to Cleerly’s office locations is expected (Denver, New York) approximately twice per year.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $145,000 - $160,000
• TTC: $166,000 - $184,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

Cleerly is entering a pivotal phase of growth. As we scale to a broader commercial footprint, we are seeking a Vice President of Regulatory Strategy and Innovation to serve as a strategic partner, reporting to the Chief Regulatory Officer.

In this role, you will be responsible for defining and operationalizing the long-term regulatory vision for Cleerly, ensuring that regulatory strategy is fully integrated into enterprise planning, portfolio prioritization, and global expansion.

You will move beyond the execution of submissions to architect the global regulatory infrastructure required for a high-growth, AI-driven medical technology company. You will position Regulatory Affairs as a strategic enabler of innovation, competitive differentiation, and sustainable global compliance.

About the Team

You will join a high-performing RA/QA organization transitioning from a submission-focused model to a strategy-led, enterprise-integrated function. We navigate novel regulatory pathways for AI-enabled diagnostic and interventional planning tools deployed in high-stakes clinical environments.

The Regulatory function at Cleerly plays a central role in shaping product strategy, risk management, claims governance, and global market access. This position will further elevate Regulatory as a proactive, forward-looking function aligned with the RAPS Regulatory Competency Framework and executive-level leadership expectations.

Position Summary

As Vice President, Regulatory Strategy and Innovation, reporting to the Chief Regulatory Officer, you are accountable for defining the enterprise-wide regulatory strategy and ensuring sustained global compliance across Cleerly’s product portfolio.

You will lead the evolution of Regulatory Affairs from a high-performing operational team to a digitally enabled, intelligence-driven strategic function. This includes establishing scalable systems, modern regulatory infrastructure, and forward-looking governance models that support AI innovation, modular software architectures, and global expansion.

This role operates at the functional leadership level, with direct impact on Cleerly’s competitive positioning, enterprise risk posture, and long-term market strategy

Core Responsibilities

Strategic Regulatory Leadership

• Enterprise Vision: Define and execute the long-term regulatory strategy aligned with corporate growth objectives and portfolio expansion.
• Portfolio Architecture: Architect regulatory strategies enabling independent iteration of AI algorithms distinct from core platforms, defining regulatory logic for modular systems (AI engines, reporting engines, workflow tools).
• New Clinical Frontiers: Lead regulatory assessments supporting expansion into broader clinical workflows bridging diagnostic imaging and treatment planning.
• Global Market Strategy: Operationalize market access beyond the U.S. (EMEA, GCC), harmonizing technical documentation under an “assess once, submit many” framework.
• Policy & Governance Ownership: Establish and approve regulatory policies, standards, and governance models that ensure enterprise-wide compliance and consistency.
• Executive Advisory Role: Serve as a key advisor to executive leadership on regulatory risk, emerging policy trends, and strategic expansion opportunities..

Regulatory Operations, Digital Transformation & Intelligence

• Regulatory Infrastructure Modernization: Lead implementation and optimization of Regulatory Information Management (RIM) systems and integration with eQMS platforms.
• AI-Enabled Regulatory Intelligence: Develop internal regulatory intelligence capabilities leveraging AI to monitor evolving global regulations (FDA, EU MDR, EU AI Act, IMDRF) and proactively assess impact.
• Claims Governance: Ensure commercial claims remain defensible, traceable to cleared indications, and aligned with global regulatory requirements.
• Continuous Improvement: Establish scalable processes, KPIs, and performance metrics to enhance regulatory efficiency, transparency, and predictability.
• Budget & Resource Stewardship: Develop and manage departmental budgets and long-range resource planning aligned with corporate growth.

External Relations & Industry Influence

• Health Authority Engagement: Serve as primary executive representative before global regulatory authorities on high-impact strategic matters.
• Industry Leadership: Engage in industry forums and policy discussions influencing regulatory frameworks for AI/ML-enabled medical devices.
• Regulatory Foresight: Analyze societal, economic, and policy trends to proactively inform Cleerly’s regulatory and business strategies.

Talent Strategy & Organizational Leadership

• Organizational Development: Build and mentor a high-performing leadership team (Directors and Senior Managers).
• Talent Strategy: Partner with HR to develop succession planning, retention strategies, and executive-level capability development.
• Cross-Functional Enterprise Leadership: Lead initiatives requiring alignment across Regulatory, Engineering, Product, Clinical Affairs, Marketing, and Legal.
• Culture of Ethical Leadership: Reinforce a culture grounded in integrity, transparency, and regulatory excellence consistent with enterprise-level expectations.

Requirements

• Education and Certification
• B.S. or higher degree in a Life Science, Engineering, or related discipline.
• JD preferred.
• Regulatory Affairs Certification (RAC) highly preferred.
• Experience
• Minimum 15+ years of progressive Regulatory Affairs experience, including significant expertise in SaMD and AI/ML-enabled medical technologies.
• Experience with Class II/III cardiovascular devices strongly preferred.
• Minimum 7–10 years of leadership experience, including managing managers and multi-level teams.
• Demonstrated experience defining global regulatory strategy under EU MDR and international frameworks (including GCC markets).
• Proven record of executive engagement with global regulatory authorities.
• Technical Expertise
• Deep understanding of software development lifecycle (SDLC), agile methodologies, and application of IEC 62304 and ISO 14971 within modular and AI-enabled architectures.
• Experience integrating regulatory strategy into product development and commercialization planning.
• Experience implementing or modernizing RIM, eQMS, or digital regulatory infrastructure strongly preferred.
• Executive Competencies
• Strategic Foresight: Ability to synthesize complex regulatory landscapes and define clear long-term direction.
• Business Acumen: Integrating regulatory insights into portfolio prioritization and commercial strategy.
• Courageous Leadership: Navigating ambiguity in emerging AI regulations while maintaining rigorous compliance standards.
• Enterprise Influence: Ability to align and influence cross-functional and executive stakeholders.
• 40% travel 

Compensation

The base salary range for this role varies by location and is aligned to market benchmarks. Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range. Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 20% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $280,000 - $300,000
• TTC: $336,000 - $360,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

Cleerly, Inc. is a technology-based healthcare company whose mission is to create digital care pathways to prevent heart attacks. Cleerly, Inc, in Denver, CO is seeking an Engineering Manager, Software to assist with the development of the next generation healthcare diagnosis system, with cutting-edge technologies.  

Job responsibilities and duties include: 

• Lead and support the engineering team throughout the full software development lifecycle for FDA 510(k) regulated medical device software (SaMD). 
• Collaborate with clinicians, regulatory, and quality teams to ensure software development aligns with IEC 62304, ISO 13485, and other relevant standards. 
• Drive decomposition of clinical and regulatory product requirements into actionable technical designs and software features. 
• Manage and mentor engineers, fostering expertise in healthcare software, image processing, and cardiac CT workflows. 
• Collaborate with AI/ML teams to integrate validated algorithms into the clinical product, ensuring regulatory compliance, performance, and usability. 
• Ensure compliance with cybersecurity, HIPAA, and FDA guidance for medical device software. 
• Define and contribute to agile practices tailored to regulated environments, including CI/CD with validated pipelines and automated testing under design controls. 
• Partner closely with product managers, radiologists, and data scientists to ensure clinical accuracy and usability of solutions. 
• Oversee risk management activities, including software hazard analysis and mitigation. 
• Participate in cross-functional design reviews, regulatory audits, and technical file preparation. 
• Recruit and onboard top engineering talent with experience in healthcare and regulated domains.  

Requirements:  

• Bachelor’s degree in Computer Science, Software Engineering, or related discipline (Master’s preferred). 
• 8+ years of software engineering experience, including 2+ years in management/leadership roles. 
• Demonstrated experience in medical device software development or healthcare technology, ideally with FDA 510(k) submissions or CE marking. 
• Strong programming skills in Python, TypeScript/JavaScript, Node.js, React, and SQL/NoSQL databases. 
• Experience developing and securing RESTful and GraphQL APIs. 
• Familiarity with AWS cloud services and infrastructure-as-code (Terraform, CloudFormation). 
• Experience integrating AI/ML algorithms into production healthcare or medical device software, including validation and performance monitoring. 
• Deep understanding of medical imaging (DICOM, PACS, cardiac CT) is a strong plus. 
• Knowledge of IEC 62304, ISO 14971 (risk management), ISO 13485 (QMS) and other regulatory frameworks. 
• Excellent verbal and written communication skills for both technical and clinical audiences. 
• Ability to thrive in a fast-paced, startup-like environment while maintaining regulatory discipline. 
• Passion for mentoring engineers and advancing clinical innovation in cardiovascular care. 

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $190,000 - $219,000
• TTC: $218,000 - $251,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We’re looking for our next Senior Technical Program Manager, an experienced scrum master who knows how to shepherd a product portfolio through the full product realization cycle while navigating competing priorities for a regulated product. 

What would I be doing?

You’ll be responsible for driving Cleerly’s product realization process. You’ll help to lead the development team from planning through verification and validation to produce the best possible solution in a compliant, high-quality, and timely manner. You’ll have strong experience in risk management and delivering products in a regulated environment, such as software as a medical device (SaMD). On any given day you could be doing any of the following:

• Communicating and coordinating activities across the product, engineering, AI, regulatory, and quality teams
• Developing and maintaining SOPs, work instructions, and other process documentation for the team and ensuring team alignment and compliance 
• Leading risk analysis activities in accordance with ISO 14971 and IEC 62304
• Tracing requirements to product architecture, system design and verification/validation test cases for compliance and regulatory needs
• Coordinating with AI scientists, engineers, and product managers to develop documentation to support regulatory submissions
• Running agile ceremonies and orchestrating sprint and project milestones in coordination with Product Management
• Ensuring that engineers have all of the information, requirements, acceptance criteria, and designs they need to implement and deliver new features and functionality effectively and efficiently
• Coordinating with engineering managers and product managers on release planning activities, timelines, and documentation
• Leading bug triage and prioritization with the team 

Qualifications

• 5+ years of technical program manager experience, or an equal combination of relevant experience in related disciplines
• Experience working in a highly regulated medical device environment with ISO 13485, ISO 14971, IEC 62304, AAMI TIR 45 standards and regulations
• BS in Engineering preferred or other relevant field with prior experience
• Certified scrum master with demonstrated experience facilitating agile processes 
• Excellent verbal and written communication skills 
• Demonstrated work history maintaining product documentation & versioning within a Quality Management System
• Ability to engage technical and non-technical audiences via strong written, verbal, and visual communication skills
• Proven ability to build relationships, collaborate, and influence internal teams and partners
• Strong analytical and problem solving skills
• Capability to succeed in a fast-paced environment with shifting priorities, and manage projects with competing priorities and timelines

Impress us more

• Previous experience working daily with data scientists, engineers, product managers, regulatory and quality team, and clinicians in a digital health environment
• Previous experience working in a start-up environment with a highly collaborative culture, wearing multiple hats as needed and “pitching in” as necessary

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $161,000 - $186,000
• TTC: $186,000 - $214,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We are seeking an accomplished Senior Product Manager to lead the release and launch of Cleerly’s AI-powered products for cardiovascular health. The Product Manager will collaborate with cross-functional teams to define product requirements, prioritize features, and deliver innovative imaging and workflow solutions that directly impact the diagnostic and prognostic care pathways for heart disease. This role requires a focus on understanding clinical needs, designing effective solutions, and making informed trade-offs to balance customer demands with technical feasibility. The Product Manager will be a primary contributor to product definition and will be responsible for prioritizing and articulating new opportunities in the marketplace and defining the product roadmap in alignment with the overall business objectives.

Responsibilities

• Lead the product roadmap for innovation products aligning with market demand, customer needs and company goals.
• Apply first principles thinking to understand complex clinical problem spaces and map them to effective product solutions and revenue opportunities.
• Engage with internal and external stakeholders, such as clinicians and engineering, to shape the product vision and direction; establish the voice of the customer funnel.
• Write clear business and functional requirements that support development efforts while ensuring clinical relevance and regulatory alignment.
• Understand the domain of diagnostic and prognostic care pathways for heart disease to guide product decisions.
• Prioritize features and balance trade-offs between performance, feasibility, and business impact.
• Collaborate with program management, regulatory, and engineering teams on implementation, from design and development reviews to launch, ensuring timely and high-quality delivery.
• Work closely with product management peers, marketing and leadership teams to develop and support the go-to-market strategy.
• Define, track, and interpret key product metrics to drive future product iteration, inform decisions and drive continuous improvement.
• Partner with downstream marketing and sales team on product detail and messaging and support of initial implementation of products in the field at key customer accounts.

Requirements

• 8+ years in product and portfolio management, with hands-on experience developing and launching Medtech products, SaMD, or AI-driven healthcare solutions.
• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field (MS or PhD is a plus).
• Proven track record of leading the roadmap planning, end-to-end development, launch, and iteration of complex products in fast-paced or startup environments.
• Deep understanding of clinical workflows and advanced imaging techniques, particularly in cardiology and radiology.
• Track record of managing products through the full lifecycle, from concept to launch and beyond, while anticipating future needs and problems in the roadmap.
• Strong research and analytical skills, a deep understanding of customer needs, and an ability to represent the customer as a stakeholder in detailed design team meetings.
• Skilled at breaking down complex, ambiguous, or changing problems into clear product strategies and functional requirements.
• Familiar with deep learning concepts, agile development methodologies (e.g., Agile, Scrum), and the regulatory environment (FDA, HIPAA, and global guidelines).
• Comfortable working cross-functionally including clinical, engineering, sales, regulatory, and marketing teams.
• Excellent written and verbal communication skills with the ability to influence and collaborate across teams.

Preferred Qualifications

• Strongly Preference for candidate with
• Expertise in cardiovascular diagnostics, imaging workstations, clinical workflows, and system integration (ie, PACS, EHR, HL7, FHIR). 
• Deep knowledge of cardiovascular care pathways and disease states to engage stakeholders effectively. 
• Experience with CT imaging for diagnostics within complex healthcare and enterprise imaging applications.
• Experience leading cross-functional project teams including imaging, clinical, engineering, sales, regulatory, and marketing teams.
• Track record of driving strategic ideas, building business cases, developing product roadmaps, and securing executive alignment to deliver high-impact solutions.
• Knowledge of global healthcare economics, reimbursement models, and payer dynamics.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $174,000 - $203,000
• TTC: $200,000 - $233,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We are seeking an accomplished Sr Product Manager to lead the release and launch of Cleerly’s AI-powered products for cardiovascular health. The Product Manager will collaborate with cross-functional teams to define product requirements, prioritize features, and deliver innovative AI solutions that directly impact the diagnostic and prognostic care pathways for heart disease. This role requires a focus on understanding clinical needs, designing effective solutions, and making informed trade-offs to balance customer demands with technical feasibility. The Product Manager will be a primary contributor to product definition and will be responsible for prioritizing and articulating new opportunities in the marketplace and defining the product roadmap in alignment with the overall business objectives.

Responsibilities

• Lead the product roadmap for innovation products aligning with market demand, customer needs and company goals.
• Engage with internal and external stakeholders, such as clinicians and AI scientists, to shape the product vision and direction; establish the voice of the customer funnel.
• Write clear business and functional requirements that support development efforts while ensuring clinical relevance and regulatory alignment.
• Understand the domain of diagnostic and prognostic care pathways for heart disease to guide product decisions.
• Prioritize features and balance trade-offs between performance, feasibility, and business impact.
• Collaborate with AI, regulatory, and engineering teams on implementation, from design and development reviews to launch, ensuring timely and high-quality delivery.
• Work closely with product management and leadership teams to develop and support the go-to-market strategy.
• Define, track, and interpret key product metrics to drive future product iteration, inform decisions and drive continuous improvement.
• Partner with downstream marketing and sales team on product detail and messaging and support of initial implementation of products in the field at key customer accounts.

Requirements

• 8+ years in product and portfolio management, with hands-on experience developing and launching Medtech products, SaMD, or AI-driven healthcare solutions.
• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field (MS or PhD is a plus).
• Proven track record of leading the roadmap planning, end-to-end development, launch, and iteration of complex products in fast-paced or startup environments.
• Deep understanding of clinical workflows and advanced imaging techniques, particularly in cardiology and radiology.
• Track record of managing products through the full lifecycle, from concept to launch and beyond, while anticipating future needs and problems in the roadmap.
• Strong research and analytical skills, a deep understanding of customer needs, and an ability to represent the customer as a stakeholder in detailed design team meetings.
• Skilled at breaking down complex, ambiguous, or changing problems into clear product strategies and functional requirements.
• Familiar with deep learning concepts, agile development methodologies (e.g., Agile, Scrum), and the regulatory environment (FDA, HIPAA, and global guidelines).
• Comfortable working cross-functionally including ML/AI, clinical, engineering, sales, regulatory, and marketing teams.
• Excellent written and verbal communication skills with the ability to influence and collaborate across teams.

Preferred Qualifications

• Experience leading cross-functional project teams including ML/AI,imaging, clinical, engineering, sales, regulatory, and marketing teams.
• Prior experience in the cardiovascular field with base knowledge of cardiovascular diseases and procedures, to be able to engage in thoughtful discussions with key stakeholders.
• Comprehensive knowledge of one or more medical imaging modalities (CT, MRI, Ultrasound, Fluoroscopy, etc.) and their role in diagnostic decision making, procedure planning and guidance.
• Prior experience in complex healthcare or medical imaging workflow applications and enterprise imaging solutions.
• Track record of driving strategic ideas, building business cases, developing product roadmaps, and securing executive alignment to deliver high-impact solutions.
• Knowledge of global healthcare economics, reimbursement models, and payer dynamics.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $174,000 - $203,000
• TTC: $200,000 - $233,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We are seeking a highly skilled Senior Scientist to lead the design, development, validation of innovative clinical workflow that can directly impact the diagnosis and treatment for heart disease. In this senior-level role, you are responsible for architecting a cutting-edge product that integrates our existing technologies while pushing the boundary of innovation in cardiac vascular imaging. You will also represent the company in strategic research collaborations with leading academic and clinical institutions, driving innovation at the intersection of AI and cardiovascular health.

About the Team

You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly’s regulated products.

Responsibilities

• Research and develop state-of-the-art AI and non-AI algorithms for coronary CT imaging applications.
• Translate product and clinical requirements into algorithmic specifications in collaboration with Product and Clinical teams.
• Partner with Regulatory Affairs to support regulatory submissions (e.g., 510(k), De Novo,PCCP), including generating evidence and documentation.
• Collaborate with engineering teams to deploy AI and non-AI based solutions in clinical practice.
• Communicate findings and strategy to internal stakeholders through clear technical documentation, presentations, and demos.
• Contribute to intellectual property development through patents and scientific publications.

Requirements 

• Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field, with 3+ years combined postdoc and/or industry experience; OR an M.S. with 5+ years of relevant experience.
• R&D experience in medical image processing, demonstrating subject matter expertise in deep learning methods for image quality enhancements, optical flow analysis and CT harmonization.
• Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis).
• Strong experience in Python, Tensorflow and pytorch.
• Prior experience with ITK, OpenCV, VTK.
• Excellent interpersonal, cross-functional, and cross-cultural collaboration skills.

Preferred qualifications

• 3+ years of industry experience in AI-based medical device development or clinical deployment.
• Experience supporting FDA regulatory submissions for ML-based software, including familiarity with De Novo, 510(k), and PCCP pathways.
• Deep domain knowledge in cardiovascular imaging and CT interpretation workflows.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $186,000 - $212,000
• TTC: $214,000 - $245,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

As a Senior Product Designer specializing in the referring physician experience, you will be a key driver in shaping how physicians and their staff order, consume, and interpret complex coronary analytics. You will partner closely with Product Management, Engineering, Commercial, BI teams to transform complex metrics into intuitive and scalable dashboards and software solutions. We value exceptional design craft and are looking for a designer who can operate with high autonomy and find opportunities to transform constraints into feasible, outstanding user experiences that are core to our mission of transforming cardiac standard of care and freeing the world from heart attacks.

About the Team

Cleerly's leadership in cardiovascular care innovation and product development offers significant opportunities for passionate and mission-driven individuals. You will join a high-performing Product Design function that is valued and supported by executive leadership. We are committed to driving measurable impact across our products with a focus on improving customer delight, increasing adoption and ensuring scalability.

Responsibilities

• End-to-End Product Design: Lead the entire design lifecycle focused on the referring physician experience, driving projects from discovery through launch, managing deadlines, and ensuring stakeholder alignment.
• Outcome-Driven Accountability: Directly drive a quantifiable reduction in operational friction by designing highly efficient, scalable, and error-minimized workflow solutions.
• Design Craft & System Stewardship: Apply superior information architecture, interaction, and visual design craft to all deliverables. Actively contribute to and leverage the Design System to accelerate product realization and elevate the quality baseline.
• Feasible Design Delivery: Serve as a core partner to Engineering and QA, understanding technical constraints and ensuring that delivered designs are viable for efficient implementation.
• Strategic Influence & Thought Leadership: Serve as thought partner to Product Management, Engineering, and Commercial teams, actively providing informed design perspectives and driving strategic cross-functional decisions.
• Evidence-Based Optimization: Conduct deep discovery research such as informal guerilla testing to more structured task-based analysis, to identify friction points and opportunities for improvements within complex multi-user workflows.
• Risk-Based Design: Perform regulatory-compliant human factors engineering activities such as task analysis, risk-based formative usability evaluations, use-related risk analysis, and actively contribute to the cross-functional risk management efforts.
• Design Advocacy & Communication: Employ outstanding communication and storytelling skills to distill complex workflow issues into clear, engaging narratives, actively amplifying the voice and business impact of design company-wide.

Required Qualifications & Skills

• 8+ years of professional experience in Product Design with a strong portfolio and case studies demonstrating expertise in complex B2B, analytics, and dashboarding solutions.
• Comfortable working in a fast-paced, innovative startup environment where changes are frequent, maintaining a positive attitude toward ambiguity.
• Proven ability to tackle complex products from start to finish with high autonomy, demonstrating a track record of driving and measuring quantifiable improvements in business and user outcomes.

Additional Requirements

• Expert proficiency with Figma’s advance features and familiarity with AI-powered user research tools for qualitative (e.g. Dovetail) and quantitative research.

• Experience with rapid prototyping leveraging design systems and AI (Figma Make, Figma MCP Server, Lovable, 3Cursor, etc).
• Experience in the HealthTech, SaMD or other domains with complex data and specialized workflows.

• Experience designing applications involving medical imaging or large-scale scientific data.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $166,950 - $192,180
• TTC: $191,992.50 - $221,007.00

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.

About the Opportunity

We're seeking a Senior Software Engineer to drive key technical initiatives across our computational imaging pipeline. In this high-impact role, you'll own the complex systems responsible for deploying, scaling, and monitoring our regulated AI algorithms end-to-end. You will influence the architecture of our system, ensuring our solutions meet medical standards for quality and performance, while mentoring other engineers and helping shape our technical culture.

About the Team

You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly’s regulated products.

Responsibilities

• Design, build, and deploy scalable AI services and computational imaging pipelines to production, ensuring robust, high-availability infrastructure for our machine learning algorithms.
• Design extensible system architectures and make pragmatic trade-offs that balance performance, security, and maintainability.
• Own full lifecycle delivery of complex features, from architectural planning and API design to implementation and post-release observability.
• Ensure high availability and observability of our services; improve alerting, logging, and incident response across the stack.
• Set and uphold strong engineering standards via code reviews, technical mentorship, and design documentation.
• Lead technical design reviews and system decomposition efforts across teams.
• Proactively identify risks and gaps in operational or architectural resilience, and drive durable improvements.
• Collaborate closely across AI and engineering to reduce knowledge silos and ensure continuity in critical systems through cross-training and documentation.
• Design and implement robust testing mechanism and validation strategies to ensure compliance with our Quality Management System and regulatory standards 
• Contribute to the necessary technical documentation required for regulatory submissions.

Requirements 

• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or related field (or equivalent experience).
• 8–12 years of software engineering experience, with expertise in AI production systems (Python, PyTorch) and data services (SQL, Postgres, NoSQL, Redis or similar).
• Demonstrable capability in designing, implementing, and securing RESTful web services
• Experience in MLOps orchestration and cloud deployment (Docker, Kubernetes).
• Experience with AWS, GitHub, and continuous integration pipelines
• Proven track record of architecting and delivering scalable systems in production environments.
• Experience mentoring engineers and raising the technical bar through reviews and design feedback.
• Strong systems thinking with the ability to evaluate tradeoffs in scalability, reliability, and maintainability.
• Experience designing for observability and operational excellence (e.g., logs, alerts, dashboards, runbooks).
• Comfortable operating in ambiguity and driving clarity across product, engineering, and business stakeholders.

Preferred:

• Experience designing and optimizing end-to-end medical imaging pipelines in a production environment and familiarity with HIPAA/HITRUST security requirements.
• Hands-on experience with Computer Vision and Deep Learning techniques used for medical image processing.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $153,000 - $179,000
• TTC: $176,000 - $206,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.