About Re:Build Manufacturing

Re:Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America’s next generation industrial company. At Re:Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We leverage deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We’ve assembled a powerful set of complimentary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we’re leveraging their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products. Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

Who We Are Looking For

Re:Build Harness Solutions is building a digital-first wire harness engineering and manufacturing platform. We are seeking a Technical Engineering Manager to lead technical execution, operational systems, and customer growth for the business. This is not a traditional engineering management role. We are looking for an ambitious leader who thrives in ambiguity, builds scalable systems, and creates long-term customer value through engineering excellence, digital innovation, and operational execution. The ideal candidate combines deep technical expertise in wire harnesses with strong customer engagement, business leadership, and manufacturing systems thinking.

What you get to do

Business & Technical Leadership

• Lead technical strategy and operational execution for the wire harness business
• Develop scalable systems for quoting, design reviews, manufacturing workflows, and customer onboarding
• Track and improve key operational metrics including quote turnaround, smartBuild-ready designs, delivery performance, and ECO reduction
• Support growth planning, investment prioritization, and business reviews

Customer Engagement & Engineering

• Lead technical discovery reviews with customers across aerospace, defense, medical, robotics, and industrial sectors  
• Translate customer requirements into manufacturable, scalable solutions
• Collaborate with commercial teams to establish Re:Build as a trusted engineering and manufacturing partner  
• Drive customer benefit through engineering optimization and rapid execution  

Digital Manufacturing & Process Innovation

• Own and improve digital wire harness workflows using Cadonix Arcadia, QuoteBuilder, AI tools, and smartBuild
• Build repeatable RFQ/RFP and production execution processes
• Partner with digital teams to accelerate automation, validation, and manufacturing integration
• Help establish Re:Build as a center of excellence for digital-native wire harness manufacturing

Manufacturing & Operational Excellence

• Support development of digitally optimized manufacturing capabilities
• Drive continuous improvement across engineering, production, and customer engagement workflows
• Align technical execution with profitability, quality, and delivery goals

What You Bring to the Team

• BS or equivalent experience in Electrical, Mechanical, or Manufacturing Engineering (advanced degree or MBA preferred)  
• 10+ years in engineering and/or manufacturing environments
• 3+ years leading technical teams in wire harness, cable assembly, or electro-mechanical systems
• Strong understanding of wire harness design, manufacturability, and production processes
• Experience with ECAD/wire harness design tools (Cadonix Arcadia preferred)
• Knowledge of automated processing, assembly, testing equipment, and regulated manufacturing environments
• Familiarity with aerospace, defense, medical, or industrial quality standards and ITAR environments
• Proven ability to build scalable systems and operational processes
• Strong customer-facing technical communication skills
• Experience managing fast-paced, high-iteration customer programs
• Ability to balance strategic thinking with hands-on execution
• Demonstrated use of data and leading indicators to drive business outcomes
• Experience with project management, ERP/MES, and PLM/PDM systems
• Comfortable using AI and digital tools to improve productivity and decision-making
• IPC/WHMA-A-620, AS9100, or equivalent

Travel up to 30% required. Preferred location: Kalamazoo, MI (Re:Build Tekna facility), with consideration for candidates near major hardtech hubs.

Compensation Range: The base salary range for this position is $138,000 – $ 208,000 per year. This range represents the Company’s good faith estimate of the base compensation for this role at the time of posting.  Actual compensation will be determined based on several factors, including but not limited to relevant experience, skills, qualifications, internal equity, and geographic location. In addition to base salary, this role may be eligible for annual incentive compensation and/or long-term incentives, subject to Company plans. The Company offers a comprehensive benefits package including medical, dental, vision, retirement, paid time off, and other benefits. 

Export Control Requirement: Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

The BIG payoff

We are a company who is going to make a difference in the industries and the regions where we choose to operate. Every employee of Re:Build will share ownership in the company and will share in the financial rewards of the success we achieve together, at all levels of the company!

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

About Re:Build Manufacturing

Re:Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America’s next generation industrial company. At Re:Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We leverage deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We’ve assembled a powerful set of complimentary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we’re leveraging their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products. Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

Who we are looking for

This is an exciting opportunity for an impactful role where you will enjoy considerable autonomy and variety. The Senior Marketing Manager is integral to the team, driving go-to-market initiatives for Re:Build’s cross-industry capabilities in industrial systems, automation, machine design/build, and battery technology. You will work closely with the business development, sales, marketing team, and technical domain experts to develop and support the entire client acquisition process and nurture ongoing relationships with existing clients and trade organizations.

The position requires a highly motivated, “roll-up your sleeves” professional fluent in business-to-business marketing of highly technical products and services. This is a very hands-on role requiring the implementation of the Re:Build marketing and business development process and supporting each company within the organization in meeting annual growth initiatives. It is a high-visibility role that impacts the entire organization.

What you get to do

• Lead the generation and flow of high-quality Marketing Qualified Leads into the sales funnel for the assigned businesses.
• Conduct targeted market and competitive research to identify trends, customer needs, and competitive positioning opportunities that advise strategic decisions.
• Develop, drive, and complete targeted campaigns to improve and sustain pipeline health in collaboration with the demand generation team.  
• Evaluate, adopt, and leverage AI-enabled marketing tools and workflows to improve campaign performance, content development, market research, lead generation, and operational efficiency.
• Champion the responsible use and adoption of AI technologies across marketing initiatives while identifying opportunities for innovation and process improvement.
• Develop, drive, and implement the marketing strategy for the capabilities in our industrial systems, automation, machine design/build, and battery technology.
• Serve as the marketing owner for designated market segments and capabilities, developing and delivering targeted go-to-market strategies that drive awareness, engagement, pipeline growth, and revenue generation.
• Own, plan, manage, and optimize spend for the annual demand generation budget to generate funnel growth and pipeline velocity.
• Develop, implement, and use creative and differentiated ideas to drive high-quality leads into the funnel and position Re:Build in the marketplace as a technical industry leader.
• Develop, drive, author, and compile technical content, including:
  • Case studies
  • Speaking engagements
  • Webinars
  • Print and digital sales/marketing
• Support overall company marketing goals and go-to-market strategy.
• Support and influence the tradeshow calendar by targeting relevant events for our product innovation and engineering services businesses
• Identify, develop, and implement strategy for non-traditional market segments.
• Track and report on the efficacy of marketing programs and initiatives and recommend adjustments to strategy.

What you bring to the Team

• Extreme attention to detail and exceptional organizational skills
• Self-motivated with the ability to work independently
• Comfortable with multitasking in a fast-paced and time-sensitive environment  
• Excellent written and verbal communication skills
• Curious, fast-learning, and resourceful
• Demonstrated curiosity and adaptability in learning and applying emerging AI tools and technologies to enhance marketing effectiveness and productivity.
• Applied understanding of basic marketing principles
• Creative problem-solving skills
• Ability to work well with a remote team
• Ability to prioritize tasks and meet deadlines in a fast-paced environment
• Comfortable with using metrics to strive for continuous improvement and demonstrating the value of marketing initiatives

Education and/or Experience:

• Bachelor’s degree or equivalent experience in engineering, marketing, or a related field
• Minimum of 8 years of professional experience in a marketing position in an industrial systems, engineering, automation, or manufacturing company; experience in engineering-based role prior to working in marketing would be ideal
• Competency and fluency in Account Based Marketing (ABM), Paid Media, Automation, CRO, SEO, PLG, activation, and retention
• Strong background of driving demand-generation programs that deliver measurable business results, including pipeline and revenue
• Proven experience developing and accomplishing unified campaigns across multiple channels, including email, webinars, paid media, events, and social media
• Proficient with Microsoft Office 365 Suite
• Competent with the Adobe Creative Cloud Suite of products (Photoshop, InDesign, and Illustrator)
• Familiarity or experience with HubSpot
• Experience leveraging AI tools (e.g., generative AI, marketing automation, analytics, or content optimization platforms) to improve business outcomes is strongly preferred.

Export Control Requirement: Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

The base salary range for this position is $ 105,000 – $150,000 per year. This range represents the Company’s good faith estimate of the base compensation for this role at the time of posting.  Actual compensation will be determined based on several factors, including but not limited to proven experience, skills, qualifications, internal equity, and geographic location. In addition to base salary, this role may be eligible for annual incentive compensation and/or long-term incentives, subject to Company plans. The Company offers a comprehensive benefits package including medical, dental, vision, retirement, paid time off, and other benefits. 

The BIG payoff

We are a company who is going to make a difference in the industries and the communities in which we choose to operate.  Every employee of Re:Build will share ownership in the company and will share in the financial rewards of the success we achieve together, at all levels of the company!

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

Re:Build is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at accommodations.ta@ReBuildmanufacturing.com or you may call us at 617.909.6275.

About the Role >>> Submission Content Manager, Regulatory Operations 

The Submission Content Manager plays a critical role within Regulatory Operations by preparing regulatory submission documents for final publishing and delivery to global health authorities. This position ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission. The role partners closely with Regulatory Affairs, Medical Writing, CMC, Nonclinical, and Clinical teams to ensure high-quality, compliant, and timely regulatory submissions (e.g., INDs, NDAs, MAAs, amendments). 

The ideal candidate has strong attention to detail, experience with document management and eCTD standards, and the ability to manage multiple concurrent submission activities in a fast-paced environment. 

This role is based out of either our Cambridge, Ma or San Francisco, Ca office and may require up to 15% travel. 

Your work will primarily encompass: 

Document Preparation & Formatting 

• Prepare and format submission-ready documents, including applying PDF standards, bookmarks, hyperlinks, headers/footers, and accessibility elements
• Ensure all documents meet technical standards (e.g., PDF/A compliance, OCR/searchability, file size limits)
• Verify that tracked changes, comments, draft watermarks, and metadata are removed before pre-publishing
• Serve as a subject-matter expert for the Starting Point templates and provide training, guidance, and support to cross-functional teams on how to use these templates effectively

 Submission Assembly Support 

• Assist Regulatory Operations staff in assembling and preparing eCTD sequences for publishing
• Coordinate with submission teams to confirm final document versions and readiness for publishing
• Track and document issues, risks, and deviations, escalating as appropriate
• Work closely with Regulatory Affairs, Medical Writing, CMC, Quality, and Clinical teams to ensure submission accuracy and completeness

Quality Control & Compliance 

• Perform technical QC checks on documents prior to publishing, ensuring formatting, structure, and completeness
• Develop publishing standards and guidelines in coordination with Regulatory Operations and Medical Writing 
• Ensure all pre-publishing activities comply with company SOPs, regulatory guidelines, and eCTD specifications

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree is required 
• Knowledge and experience of eCTD submissions 
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM 
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking 
• Experience with StartingPoint eCTD templates or equivalent 

 Experience: 

• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Demonstrated leadership skills while working in a fast paced and changing environment
• Experience in building and submission of NDA and life-cycle management is highly desirable

Attributes: 

• Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working 
• Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines 
• Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives  
• Excellent written and verbal communication skills 
• Excellent negotiation and organizational skills 

The base pay range for this position is expected to be $145,000 - $155,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

This is a part-time consulting role for 20hr/week. Duration of the project will be approximately 3-4 months. Preference will go to candidates in the Boston area. 

Your impact:

As the AI Adoption Consultant, you will bridge the gap between cutting-edge artificial intelligence and the complex workflows of a modern biotechnology organization. Your mission is to accelerate the integration of AI tools across the enterprise, moving beyond the "hype" to deliver tangible improvements in operational efficiency and scientific output.

You will partner with leaders in Research, Clinical Operations, Finance, IT, and People & Culture to identify high-impact opportunities, design implementation roadmaps, and lead a culture-shifting training program to ensure every employee is "AI-fluent."

Your day-to-day:  

• Conduct deep-dive discovery sessions with functional leads (Finance, IT, Research, etc.) to map existing workflows and identify bottlenecks.
• Build a prioritized "AI Opportunity Roadmap" that balances quick wins with long-term strategic shifts.
• Evaluate and recommend third-party AI tools or internal LLM applications that meet the specific security and compliance standards of the biotech industry.
• Collaborate with the CIO and IT team to ensure AI deployments are scalable, secure, and integrated into the existing tech stack.
• Develop and deliver tailored training modules for diverse audiences—from "AI for Scientists" to "Prompt Engineering for Finance Professionals."
• Create "Office Hours" and internal communities of practice to foster continuous learning and peer-to-peer knowledge sharing.
• Work with Legal and IT to establish clear guidelines for the ethical use of AI, particularly regarding sensitive data and intellectual property.

Must-Haves:

• Experience: 5+ years of experience in digital transformation, management consulting, or a similar role, with at least 1-2 years focused specifically on AI/ML implementation.
• Industry Knowledge: Direct experience in the Biotech or Pharmaceutical sector is highly preferred.
• Technical Fluency: A strong understanding of Large Language Models (LLMs), Generative AI tools, and data orchestration. You don't need to be a coder, but you must be able to speak the language of both data scientists and end-users.
• Communication: Exceptional ability to translate complex technical concepts into "business value" for non-technical stakeholders.
• Education: Bachelor’s degree in a relevant field (CS, Data Science, Business, or Life Sciences).

Your impact:

As a Senior Clinical Trial Associate, you’ll be a key player in keeping our clinical studies on track—managing the details, supporting the team, and helping bring innovative treatments to patients

Your day-to-day:  

• Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF's, monitoring visit reports, etc.
• Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs
• Perform quality checks on the study TMF with oversight of study COL
• Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc. May coordinate and track clinical trial equipment and supplies
• Review and track vendor invoices against contracts with oversight of study COL
• Coordinates and tracks administrative aspects of contract execution and PO generation
• Supports the trial team to produce and distribute study newsletters
• Supports collection and updating of clinical trial insurance
• Supports posting of all agreed clinical trials to publicly available websites
• Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc.
• May support additional ad-hoc activities as agreed with the study COL

Must-Haves:

• Bachelor's degree in life sciences or healthcare related field
• 3+ years' experience in a clinical trial support position, experience in Biotech or Pharma strongly preferred
• Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
• Solid understanding of the responsibilities and needs of other functions in a clinical trial
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Ability to multitask and flex across projects as priorities and deadlines shift
• Ability to maintain confidentiality of proprietary information
• A team player that takes initiative and is proactive 

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $90,000-$110,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

This role is onsite in our Boston office. We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

We are hiring a Head of Chip Architecture, you will collaborate with both external partners and internal engineering teams to develop and deliver innovative, high-volume photonics products. In this role, you will define advanced chip architectures for co-packaged optics, working closely with cross-disciplinary teams to model, analyze, and optimize system performance. Success in this role requires deep domain expertise in silicon photonics, high-frequency (50+ GHz) electro-optic interfaces, lasers, optical amplifiers, fiber-optic communications, and packaging/assembly techniques. Strong analytical problem-solving, effective communication, and technical leadership are essential. You will be expected to be the primary technical liaison for key customers, partners, and internal stakeholders. You will also represent Lightmatter’s at premier industry conferences.

Join a tight-knit team where each individual’s contributions directly influence the success of the company and product. You'll have the opportunity to build a new kind of computer from the ground up and to solve groundbreaking challenges along the way. Work with people who love to build and who thrive in technically diverse environments where great ideas are prioritized.

Responsibilities: 

• Guide, coach, and mentor a team of chip architects from different domains: photonics, digital, and analog. 
• Define chip architectures for datacenter/AI compute optical interconnect demonstrations and products. 
• Lead the co-optimization of SerDes, analog front ends, and optical transceivers to achieve best-in-class performance in terms of performance, energy efficiency, and costs.
• Work with other engineering leaders to plan, set, and execute on development, tapeout, and validation timelines.
• Provide technical leadership to cross-functional engineering teams.
• Represent the architecture team in executive-level reviews, industry forums, and customer negotiations.
• Act as the primary technical liaison for key customers, partners, and stakeholders regarding our current chip’s architecture and future roadmap.
• Drive the technical selling process by clearly articulating the competitive advantages, performance metrics, and cost benefits to both technical and non-technical customers.
• Communicate complex technical concepts clearly to both technical and non-technical stakeholders.
• Partner with the Product and Sales teams to define next-generation photonic products.
• Research and evaluate emerging optical interconnect technologies, and drive technology roadmaps aligned with market trends and strategic objectives.
• Develop new IP. Publish technical findings at top journals and share our technical expertise at conferences.
• Be Lightmatter’s ambassador. 

This is not a complete listing of the responsibilities. It’s a representation of the things you will be doing 

Qualifications: 

• A Ph.D. degree in Electrical Engineering, Applied Physics, or a related field with 10+ years of relevant experience and leading teams.
• Must have managerial experience 
• Strong track record in managing teams and helping them grow and achieve at the highest level.
• Deep technical knowledge in photonic/AMS chip co-design.
• Proven success in developing, taping out, and bringing-up state-of-the-art photonic/AMS chips and system solutions.
• Proven track record of successfully taking at least two chip architectures from concept to high-volume production.
• Demonstrated experience serving as a primary technical point of contact with major external customers, partners, or vendors.
• Proven ability to translate complex technical concepts into compelling business value propositions for executive and non-technical audiences.
• Strong track record of planning and driving complex projects to completion.
• Ability to work cross-functionally with other organizations to achieve company-wide goals.
• Deep understanding of market trends and application of optical interconnects.
• Must to travel 30% of the time 

Preferred Qualifications:

• World-class technical leadership: demonstrated absolute technical and people excellence. 
• Strong track record of innovation in photonics as evidenced by patents and publications.
• Demonstrated creative problem-solving skills for problems that have no obvious solutions.
• Strong publication record and public speaking experience.
• Ability to retain and attract new talent.
• Executing R&D for product and market needs.
• Willingness to engage and learn quickly to ensure mission success. Self-starter with a “no task is too big or small” attitude.

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

The Director, Regulatory Systems and Operations, reporting to our Chief Regulatory Officer, serves as a strategic leader and driver of regulatory infrastructure and execution. This role partners cross-functionally with internal stakeholders to define, implement, and continuously enhance Regulatory Information Management (RIM) systems and databases, ensuring the integrity, accessibility, and scalability of all regulatory information and documentation.

In parallel, this leader plays a critical role within the global regulatory organization as co-lead of the Global Regulatory Subteam, with accountability for the strategic planning, coordination, and execution of regulatory deliverables. The Director ensures alignment of regulatory activities with development timelines and organizational priorities, driving cross-functional collaboration to deliver high-quality submissions on time.

This position works closely with the Regulatory Strategy Leads to proactively shape and advance regulatory plans across the product lifecycle, providing both strategic oversight and operational leadership to enable successful global regulatory outcomes.

Your role

Regulatory Systems

• Lead the implementation and optimization of the Regulatory Information Management System (RIMS), ensuring strong user adoption through effective training and support. Drive continuous improvement of regulatory processes and monitor key global metrics and compliance indicators to advance operational excellence.
• Interface with Tango’s IT, QA and R&D departments and with external partners (if applicable) on local regulatory system management related topics.
• Support optimization of publishing best practices and global submission standards in accordance with regulatory requirements worldwide.
• Build and maintain relationship with external vendor partners (e.g. publishing).
• Support system audit and/or GxP inspection or due diligence with regard to regulatory systems and regulatory documentation.
• Define global processes to ensure compliance with the regulation. Build regulatory policies and procedures and ensure that these processes are adhered to.

Regulatory Project Management

• Lead project management activities related to the preparation and tracking of regulatory documents/submissions.
• Co-lead and coordinate the Global Regulatory Sub-Team (GRST) for assigned programs, driving operational regulatory activities in partnership with the RA strategist. Lead GRST meetings, track key deliverables, and proactively manage risks and mitigation plans.
• Drive timelines and deliverables related to submission documents. Track progress and review project(s) tasks to meet deadlines. Point of contact re: timelines and status of submissions / approvals / responses and commitments globally.
• Lead the day-to-day operation of the Dossier Task Force/filing team and ensure compliance with dossier compilation and global submission processes.
• Establish clear ownership for project tasks, ensure that team members have the tools needed. Communicate process and document standards to stakeholders.
• Identify and communicate critical processes or issues in project(s) and develop solution strategies together with the regulatory lead and project team functional representatives and/or head of function, when relevant.
• Responsible for the overall publishing activities for the assigned product. Establish good relationship with publishing vendor. Ensure timely, high quality dossier assembly and publishing in accordance with Submission Content Plan.

What You Bring

• Minimum of 10 years of Regulatory Operations experience, with a BA/BS or equivalent required; advanced degree preferred
• Strong knowledge of Veeva RIM systems
• Demonstrated success in defining and implementing new operating standards and regulatory processes
• Extensive experience in Regulatory Affairs project management within drug development, including leading cross-functional development teams
• Deep expertise in regulatory publishing requirements and constraints, with hands-on experience managing submissions for IND, CTA, NDA, and MAA applications
• Solid understanding of electronic document management systems, regulatory databases, publishing platforms, and related technologies
• Self-motivated, adaptable, and innovative leader with the ability to prioritize, manage multiple projects, and thrive in a fast-paced, dynamic environment; strong problem-solving skills with the ability to develop and implement effective solutions
• Strong organizational and project management capabilities
• Excellent written and verbal communication skills, including presentation and facilitation 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#LI-Hybrid

The Opportunity

If you've worked alongside hardware teams, you know the damage that results from a missed change request or critical context that was never relayed to the right person. Reflow exists to close that gap. We're building the first AI-powered platform built for hardware product development, one that listens across the tools teams already use, maintains a structured picture of every program, and proactively coordinates across disciplines when things inevitably change.

This is an early role for a hands-on AI engineer to design and build the agents at the core of our platform, backed by a parent company with deep roots in engineering and manufacturing. You'll own the AI systems that set our product apart: agents that understand hardware workflows, anticipate problems, and take action on behalf of engineering teams.

Who We're Looking For

We're looking for an AI engineer who works equally well in applied research and production software. You've shipped LLM-powered agent systems to real users, you have strong intuitions about prompt engineering, tool use, and orchestration patterns, and you keep up with a field that changes fast. You're comfortable evaluating new frameworks, models, and techniques on short cycles and making pragmatic build-vs.-adopt decisions as the landscape shifts.

We currently use LangChain's DeepAgent framework for our agent orchestration, but every layer of our AI stack is open to change. The right person for this role understands how agent systems work under the hood, not just one framework's abstractions, and can adapt as better tools and approaches emerge.

This senior engineer will work alongside our engineering team and head of product to build, optimize, and operate the AI agents that give users proactive coordination, risk surfacing, status summaries, and AI-generated deliverables. The role is hands-on. You'll write code daily while contributing to AI architecture decisions and helping define how we evaluate and evolve our agent capabilities over time.

What You'll Do

Your day-to-day responsibilities will include:

• Designing, building, and iterating on LLM-powered agents that coordinate across engineering disciplines, surface project risks, and generate structured deliverables (proposals, SOWs, status reports)
• Owning the agent orchestration layer (currently LangChain DeepAgent) and continuously evaluating whether to extend, replace, or supplement it as new frameworks and patterns emerge
• Implementing robust tool-use patterns that connect agents to external systems (project management tools, CAD/PLM platforms, communication channels) via APIs and integrations
• Designing and tuning prompts, chains, and retrieval strategies to maximize agent reliability, accuracy, and usefulness across diverse hardware project contexts
• Building evaluation and observability infrastructure for agent performance, including tracing, cost tracking, latency monitoring, and automated quality benchmarks
• Developing streaming agent interfaces that surface real-time progress, reasoning transparency, and proactive alerts to end users
• Staying current with rapid advances in LLMs, agent frameworks, and related tooling, and translating that awareness into actionable recommendations for the team
• Collaborating with frontend engineers on the UX of AI-powered features and with backend engineers on data pipelines and API design
• Contributing to AI architecture decisions, code reviews, and engineering best practices

Technical Requirements

Must Have:

• 5+ years of production software engineering experience, with 2+ years focused on bringing LLM-based applications or agent systems to market
• Demonstrated proficiency using AI coding tools (Cursor, Copilot, Claude, etc.) to accelerate development
• Hands-on experience building and deploying agentic systems using frameworks such as LangChain/LangGraph, CrewAI, AutoGen, or custom orchestration
• Strong understanding of LLM fundamentals: prompt engineering, function/tool calling, retrieval-augmented generation (RAG), context window management, and token economics
• Proficiency with Python in production environments
• Experience integrating LLM-powered features with external APIs, databases, and third-party tools
• Experience designing and operating background job / async task pipelines (Celery, RQ, Temporal, or similar) for long-running agent runs and reliable retries
• Experience building multi-agent systems with planning, delegation, and inter-agent communication patterns
• Demonstrated ability to evaluate and adopt new AI tools and frameworks quickly, with a track record of staying ahead of a fast-moving field
• Strong software engineering fundamentals: clean architecture, testing, version control, and code review practices
• Ability to balance rapid experimentation with production-grade reliability

Highly Valuable:

• Direct experience with LangChain's DeepAgent or LangGraph for multi-step agent orchestration
• Background in evaluation frameworks for LLM outputs (automated scoring, human-in-the-loop evaluation, regression testing for prompts)
• Familiarity with vector databases and embedding pipelines (Pinecone, Weaviate, pgvector, or similar)
• Experience with model serving infrastructure, fine-tuning workflows, or model selection/routing strategies
• Understanding of authentication/authorization patterns (OIDC, JWT) and secure handling of user data in LLM contexts
• Background in B2B SaaS platforms, project management tools, or technical collaboration products
• Familiarity with hardware development, engineering workflows, or project management concepts (phases, gates, dependencies, requirements traceability)
• TypeScript / React fluency, enough to pair with frontend engineers on streaming agent UIs and reasoning-transparency surfaces

What We Offer

Real Impact: The opportunity to build purpose-built tooling for an entire industry that has never had it

Customer Access: Direct exposure to hundreds of real hardware projects annually through Re:Build's engineering and manufacturing companies

Technical Growth: Hands-on work at the frontier of applied AI, solving novel agent design challenges with real-world feedback loops

Autonomy: Backed by Re:Build while operating with startup independence

Benefits: Full health/dental/vision, bonus program, generous 401K, paid time off, annual learning stipend

Equity & Growth: Participation in Re:Build's LTIP equity program and opportunity for founder equity in potential spin-out

Compensation & Location

Location: Remote-first, with preference for candidates in Boston, Seattle, Los Angeles, or other cities with Re:Build offices

Compensation: Base salary range of $143,000 to $215,000 with performance bonus and long-term incentive plan offered. Potential equity stake under independent spinout scenario.

Please note this role is restricted to US citizens or lawful permanent residents only due to exposure to export controlled information.

About Re:Build Manufacturing

Re:Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America's next generation industrial company. At Re:Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We harness deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We've assembled a powerful set of complementary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we're using their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products. Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

Re:Build is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at accommodations.ta@ReBuildmanufacturing.com or you may call us at 617.909.6275.

This role is based in Boston, MA with onsite presence required Monday-Wednesday

Your impact:

In this role, you’ll work with our Clinical Operations Leads to help keep trials running smoothly across multiple indications. It’s a hands-on, high-impact role on a fun, driven team where you’ll grow fast and make a real difference. 

Your day-to-day:  

• Provide support to the Clinical Operations Lead (COL) in the planning, execution, and oversight of a global phase 3 clinical trial from study start-up to close-out.
• Support the development, review and tracking of study-related documents (protocols, ICFs, investigative brochure, monitoring visit reports, etc.) with cross functional team collaboration.
• Support start-up activities to help accelerate country and site activations.
• Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
• Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.
• Maintain and organize trial documentation (e.g., TMF/eTMF oversight, trackers, meeting minutes) ensuring that study documentation is in a continuous state of inspection readiness.   
• Contribute to inspection readiness activities and ensure compliance with GCP and SOPs.
• Help identify and resolve site risks and/or issues to foster positive site relationships.
• Coordinate internal team meetings and participate in cross-functional study meetings.
• Proactively communicate study updates with key internal and external stakeholders.

Must-Haves:

• Bachelor’s degree preferably in life sciences or healthcare related field.
• 5+ years of clinical operations experience within the biotech or pharma industry required
  • Title and level commensurate with experience  
• Experience managing outsourced global clinical trials across Phase I–III.
• Prior involvement in study start-up activities strongly preferred
• Solid understanding of GCP, ICH guidelines, and the clinical development process.
• Experience with clinical trial management systems (CTMS), eTMF, and other operational tools.
• Ability to multitask and flex across projects as priorities and deadlines shift.
• Highly organized with excellent communication and interpersonal skills.
• Strong attention to detail and ability to multitask in a dynamic, fast-paced setting.
• A collaborative team player that takes initiative.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for the Associate Clinical Trial Manager is $115,000-$135,000 and for Clinical Trial Manager it is $140,000-160,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.

Who We Are

Boston-based company Piaggio Fast Forward Inc. (PFF) was founded in 2015 by the Piaggio Group (the Italian manufacturer that created the iconic Vespa scooter). We are on a mission to build technology products that move the way that people move. To bring products to market today, PFF is solving the problem of robotic interaction with people in dynamically changing environments. We’re innovators, neighbors, and creators with a passion for local living and pushing the limits on urban transportation. We support a sustainable mobility ecology with healthy lifestyles and social connectivity available to all, regardless of age or abilities.

The Role

Piaggio Fast Forward (PFF) is looking for a Mechanical Engineering machinist to join our team. In this role, you will take ownership of the machine and assembly shop, ensuring it is well-maintained, organized, and stocked. You will work collaboratively with the Mechanical team for the in house prototyping of parts, create fixtures for the Design team, and support the Manufacturing team with part reworks or assembly fixtures. On a daily basis you will primarily be interacting with the Mechanical engineering team, therefore strong communication skills and ability to communicate technical part machining information are necessary. This is an hourly position for an individual contributor role reporting to the Mechanical Engineering Manager.

What You Need (Requirements)

• High School diploma or equivalent; Associate’s degree or technical certificate in engineering technology, or a related field is preferred
• Machine shop skills : experience including but not limited to mills, lathes, laser cutter, drill press, bandsaw, dremel, jigsaw, sawsall
• 2 - 5 years hands on experience in a machine shop or manufacturing environment preferred
• Strong work ethic and a go-getter attitude; able to work independently 
• Eagerness and willingness to learn new skills and new tools
• Ability to interpret 2D engineering drawings to ensure part compliance
• CAD experience is a plus
• Must be able to lift and carry up to 70 pounds as well as stand for long periods of time

Applicants will be asked to provide a portfolio or examples of projects completed.

What You’ll Do (Responsibilities):

• Daily work on the mill, lathe, metal saw, and precision measuring
• Mill work for aluminum hog out parts or unique prototype to match drawing spec provided from engineering
• Lathe work for precision steel drive shafts for prototyping purposes
• Create basic carpentry structures for pseudo rooms / wall fixtures for robot behavioral studies based on sketches
• Maintain equipment and work area in a clean and orderly condition; General shop upkeep
• Ownership of the machine shop space
• Manage inventory of tools, hardware, shop supplies, etc.
• Utilize purchase request system to keep MDF stocked, coordinate basic hardware orders for shop nuts & bolts bins, order parts for machine repairs 
• Perform routine maintenance on shop equipment to ensure in good working order
• Safety training for using equipment (mill, lathe, bandsaw); assist in general safety knowledge outside of machine guards and for eye wash stations and fire extinguishers locations
• Assembly and disassembly of complex mechanical mechanisms, including test fixtures
• Other responsibilities as needed

We like you just the way you are.
Diversity fuels our innovation. Inclusion, belonging, equity, and neurodiversity drives our best-in-class culture. We strive to create workplaces where everyone feels empowered to share ideas, grow at their own pace, and work together towards a shared vision while holding each other to a higher standard. For us, DEI&B is the only way forward.

Employment Eligibility Verification
Piaggio Fast Forward participates in E-Verify, an electronic employment verification program operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA), to verify the employment eligibility of newly hired employees. Piaggio Fast Forward is an E-Verify Employer, and as such, the company will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the United States.

For more information about E-Verify, please visit the U.S. Citizenship and Immigration Services (USCIS) website: https://www.e-verify.gov/

Your impact:

High visibility role as DSPV Operations Lead, will play a critical, strategic and hands-on operational role in supporting PV across all clinical development programs.  

Your day-to-day:  

Clinical Trial Support

• Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuing compliance with regulatory timelines and global regulations and guidelines
• Oversee reconciliation activities between the safety and clinical databases, as well as business partner safety data exchange
• Identify and support the development of Safety Management Plans (SMPs), and other study specific project plans
• Work closely with Data Management of EDC development for the purposes of safety data collection including Annotated CRF reviews and associated activities.
• Collaborate with DSPV Safety Science and Data Management to prepare safety data listings and reports as needed and to participate in QC related to safety data for various reports and deliverables
• Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and other relevant teams to ensure appropriate PV processes are in place and adhered to
• Prepare and deliver training on SAE reporting processes and practices at Investigator Meetings, to CRAs, to CROs, sites, as applicable.
• Lead DSPV Trial Master File document review, QC and provision to study specific TMFs
• Support DSUR preparation by maintaining DLP and submission calendar, supporting Kick-Off Meeting activities, requests for and attainment of information from cross-functional teams
• Assist with DSPV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.

Vendor Management

• Lead day-to-day operational oversight of pharmacovigilance service provider
• Establish and/or maintain oversight of key performance indicators (KPIs), key risk indicators (KRIs), key quality indicators (KQIs), and routine operational reports
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals
• Obtain close oversight of ICSR quality including performance of QC as needed
• Oversee safety database configuration updates, system updates, maintenance, E2B gateway implementations, user account management, back-up testing, and other activities as required
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA compliance

Quality and Compliance

• Support the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for DSPV.
• Support PV audit and inspection activities, as required, and serve as SME for DSPV Operations during these activities
• Ensure DSPV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and PVAs.
• Maintain a comprehensive DSPV Quality Management System aligned with DSPV functional goals
• Prepare and present DSPV Compliance Reports to DSPV/QA forum, highlighting trends, issues, and opportunities for improvement

Must-Haves:

• Degree in Life Sciences, Pharmacy, Nursing or related field
• 8+ years of experience in PV in Biotech, Pharma, or a CRO
• 5 years of experience working with and providing oversight to PV vendors and/or hosting partners.
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER).
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance.
• Effective collaboration and interpersonal skills.
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance
• Excellent decision-making and analytical skills.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $170,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

We are seeking a Director of Clinical Supply Chain to lead end-to-end clinical supply execution for a global late-stage clinical trial. This role will have full ownership of clinical supply strategy and execution, from demand forecasting through distribution, for programs involving prefilled syringes (PFS) and autoinjectors. The successful candidate will be comfortable operating within a fast-paced environment and partnering closely with Clinical Operations, Quality, CMC, and external vendors to ensure uninterrupted drug supply for our studies. This is a great opportunity to own a critical late-stage program with real patient impact and to have the ability to shape clinical supply strategy during a pivotal stage of the company’s evolution.

Key Responsibilities 

Clinical Supply Strategy & Execution

• Own the global clinical supply strategy for late-stage programs, including demand forecasting, inventory management, and risk mitigation.
• Develop and maintain integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments.
• Ensure seamless transition and continuity of drug supply.

Drug Product Development

• Lead clinical supply activities for vials, prefilled syringes (PFS), and autoinjectors, including:
• Device assembly and packaging considerations
• Cold-chain (2–8°C) requirements
• Labeling, blinding, and re-supply strategies
• Partner with CMC and device vendors to support lifecycle changes, comparability, and scale-up impacts to clinical supply.

Vendor & Depot Management

• Manage external partners including:
• Packaging and labeling vendors
• Global depots and regional distribution hubs
• Couriers and specialty logistics providers, as appropriate
• Lead vendor selection, SOWs, budgets, timelines, and performance oversight.
• Ensure qualified shippers, temperature monitoring, excursion management, and deviation handling are done in a compliant manner.

Distribution & Regulatory Compliance

• Oversee global distribution across multiple regions, ensuring:
• Country-specific import/export requirements
• QP release and EU clinical supply compliance where applicable
• Ensure inspection-ready documentation and robust supply chain traceability.

Cross-Functional Leadership

• Serve as the clinical supply chain lead on cross-functional study teams.
• Partner closely with:
• Clinical Operations on enrollment and site strategy
• Quality on GMP/GDP compliance and deviations
• Regulatory and CMC on changes impacting supply
• Communicate risks, mitigations, and trade-offs clearly to senior leadership.

Qualifications 

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience
• 10+ years of experience in clinical supply chain / clinical supply operations.
• Direct experience managing Phase 3 clinical trials, including global distribution.
• Hands-on experience with prefilled syringes (PFS) and/or autoinjectors in a clinical trial setting.
• Demonstrated ownership of:
• Forecasting and supply planning
• Packaging, labeling, and distribution
• Vendor and depot management
• Strong understanding of GMP/GDP, ICH-GCP, and global clinical supply requirements.
• Cold-chain biologics experience (2–8°C).
• Experience transitioning programs toward commercial readiness.
• Demonstrated ability to balance strategy and execution.
• An ownership mindset, ability to anticipate risk and solve problems proactively.
• Clear communication skills and the ability to translate supply complexity into actionable decisions.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

If you’re excited to help us shape ways of working, solve production line challenges, scale manufacturing capacity, and transition new hardware products into steady-state production, we want you as an Senior Advanced Manufacturing Engineering Manager for our global headquarters team in Boston. It’s worth noting that this is not like the typical shop floor manufacturing engineering management role at a manufacturing plant.

The Job:

• Lead the activities of a team of manufacturing engineering professionals responsible for supporting an extended team of global manufacturing, supply chain, quality professionals.  
• Ongoing sustainment of manufacturing lines at our contract manufacturers + transition into production and support. 
• Characterize process & product failures on our manufacturing line, root cause investigations, corrective actions, and mistake-proofing at suppliers and contract manufacturers for component/module/product new builds and refurbishments.
• Own manufacturing process (e.g. assembly, printer calibration, verification testing, etc.) control and issue prevention; implementing tools, equipment and process methods to ensure industry-leading reliability, quality, and yield.
• Drive team collaboration and support across projects/programs as a player coach on complex engineering and operational challenges. 
• Own manufacturing technical readiness as a critical member of our cross-functional NPI teams, with specific emphasis on manufacturing return of experience, producibility, cost effectiveness, industrialization; negotiate conflicting requirements, identify lessons-learned and DFM/DFA/DFSS opportunities and share/escalate to upstream design engineers and downstream sustaining engineers.
• Manage the details of transition into manufacturing or industrialization, including resolution of first article inspections (FAI) and product/fixture assembly issues; drive maturity of manufacturing readiness; secure mass production capacity, throughput, yield, and process capability.

You:

• B.S. degree in engineering; mechanical, manufacturing engineering, aerospace, industrial, or related/equivalent field. 
• 3+ years experience in an engineering management or engineering team leadership role.
• 5+ years of technical skills, preferably experience in manufacturing engineering roles for complex electro-mechanical product industrialization at scale, including machined, sheet metal, injection molded, PCBA, linear motors, LCD, cables, and plastic components.
• Experience with remotely managed NPI and contract manufacturers, including transitioning high accuracy products from prototype to mass production.
• Expertise in production quality metrics, GD&T, and process/equipment qualification procedures.
• Proficient in methods for statistical analysis (e.g. DOE, comparison testing, Gage R&R), structured problem solving (e.g. A3, 8D, DMAIC), fault-tree), and process control (e.g. statistical process control, process capability Cp/Cpk).
• Willing to work onsite, in a fast paced environment, and occasionally coordinate with colleagues in different time zones during late evening local hours.
• Travel to vendors, suppliers, and production facilities (mostly in China) from time to time (~10-20%)

Bonus: 

• Experience with Proto, EVT, DVT, PVT, and MP product development process & life cycle
• A Six Sigma Black Green/Black Belt certified professional who can still apply and teach the problem solving and statistical body of knowledge.
• Have experience with data analysis tools (JMP, Minitab) and data visualization tool (Tableau, Power Bi, SQL, etc.)
• On Shape of Solidworks CAD modeling skills

Our Benefits & Perks:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• 401K matching and access to financial advisors
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.  

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

Your Impact

As a Senior member of the Robotics Electrical Engineering team, you will drive and engage in innovative hands-on design, development, and testing of cutting-edge electronics that are integral to AXON Robotics Products. Your extensive technical expertise, deep understanding of engineering processes, genuine passion for technology, and a demonstrated ownership mindset will be instrumental to successful designs that exceed the rigorous requirements demanded by our customers. In this role, you will own the design, development, and verification of critical electronic circuits and systems, and collaborate with product engineering connections around the globe. Additionally, as an electrical engineering expert designing world-class products, your strong technical leadership skills will influence and grow junior engineering talent as you interact with and mentor others within the teams. Join a passionate engineering team dedicated to overcoming complex challenges, and help deliver technologies that positively impact Law Enforcement, Public Safety, and their surrounding communities.

Your Day-to-Day

• Conduct research, propose, and develop innovative, industry-leading circuit designs for Axon Robotics products.
• Select, design, develop, and verify system circuitry and hardware aligned with project objectives and requirements
• Using schematic capture tools, design embedded Mixed-Signal electronic circuitry that integrates
• Team with PCB Design engineers to define, plan, implement, and inspect printed circuit board layout designs using Allegro or other layout tools
• Strong background in selection of new electrical parts and suppliers. Working with suppliers to select the best parts for your design.
• Collaborate with cross-functional engineering teams, technology partners, and manufacturing teams to oversee electronics development throughout the entire product lifecycle, from concept to mass production
• Lead schematic and layout design inspections to improve the quality of design releases and product reliability
• Develop test methods and create test plans to evaluate and validate designs effectively
• Bring up, characterize, and debug systems and circuits using lab tools such as oscilloscopes, multimeters, logic analyzers, power supplies, etc.
• Evaluate and document design outcomes, test results, and related information, then present findings to the design teams for review and further action
• Evaluate performance of circuits and assess compliance to product and regulatory requirements
• Optimize performance of electronics design using simulation tools and hands-on measurements
• Develop, evaluate, and help finalize assembly drawings, bill of materials, Geber files, and other design documentation needed for product release
• Partner with new product introduction team to develop and define test requirements documentation for PCBA board level testers and system functional test fixtures on the production line
• Knowledge sharing, mentoring and elevating skills of team members

Basic Qualifications

• Bachelor’s degree in Electrical Engineering or similar engineering discipline
• 9+ years of industry leading electronics design experience with emphasis on designing densely populated, tightly packaged, high-speed digital embedded systems, Qualcomm (or similar), high-speed memory, camera interfaces (MIPI), and digital buses (PCI, DDR, etc.)
• Highly proficient in engineering processes and expectations across all design phases, with the ability to lead hardware design and development from concept through to mass production release.
• Experienced system-level design engineer skilled in creating designs that meet product requirements. Proficient in collaborating with product and engineering teams to navigate design trade-offs and selections, ensuring a meticulous approach to minimize errors and deliver successful results
• Experience designing products for electromagnetic compatibility and protecting circuitry against electromagnetic interference and electrostatic discharge events. Familiar with typical EMI/ESD filtering and protection techniques, as well as snubber circuitry design.
• Good background in basic scripting (Python or similar). Use of scripting to help automate data collection, testing, documentation generation, etc.
• Collaborates effectively with firmware engineering to develop and debug embedded electronic systems
• Exceptional hands-on proficiency with electronics bring-up, characterization, and debug using laboratory tools: Oscilloscope, power supplies, multimeters, custom jigs, etc.
• Strong schematic design skills using industry leading design tools, including BOM development. Experience with Cadence/OrCAD desired
• Skilled in leading and collaborating with PCB and mechanical design engineers to develop PCB layouts that align with design requirements. Extensive experience in designing rigid, flex, and rigid-flex PCBs, with a strong ability to identify optimal solutions that meet system design goals
• Experience designing and debugging products to pass regulatory standards (FCC, CE, IEC, etc.)
• Independent contributor capable of developing products within cross-functional and geographically diverse engineering teams
• Experience collaborating with and managing design partners and vendors
• Strong proficiency in documentation, analysis, and presentation tools, including Word, Excel, and PowerPoint

Preferred Qualifications

• Specific experience designing/specifying motors, drive circuitry, motor position/sensing circuitry, circuits for electronic speed controllers (ESC) and associated circuitry for drones is a plus

Benefits that Benefit You

• Competitive salary and 401k with employer match
• Discretionary paid time off
• Paid parental leave for all
• Medical, Dental, Vision plans
• Fitness Programs
• Emotional & Mental Wellness support
• Learning & Development programs
• And yes, we have snacks in our offices

The Pay: Axon is a total compensation company, meaning compensation is made up of base pay, bonus, and stock awards. The starting base pay for this role is between USD 113,250 in the lowest geographic market and USD 181,200 in the highest geographic market. The actual base pay is dependent upon many factors, such as: level, function, training, transferable skills, work experience, business needs, geographic market, and often a combination of all these factors. Our benefits offer an array of options to help support you physically, financially and emotionally through the big milestones and in your everyday life. To see more details on our benefits offerings please visit www.axon.com/careers/benefits.

Your Impact:

Rapport is seeking an Associate Director / Director of Biostatistics who will have a hands-on role in shaping the design, analysis, and interpretation of clinical trial data for our precision neuromedicine programs. Reporting to the Head of Biostatistics, you will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process.

Your Day-to-Day:

• Working as a leading statistician on multiple studies/projects. Oversee the production of protocol development (study design, endpoint selection, sample size calculation and statistical methods) and Statistical Analysis Plan (SAP) that lead to comprehensive clinical study reports suitable for regulatory submissions.
• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans
• Support statistical programming to plan, execute and deliver SDTM and ADaM datasets, tables, listings, and figures (TLFs). Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
• Provide statistical input and the interpretation of results to clinical study reports, regulatory submissions documents, and publications, in collaboration with the clinical, regulatory, and medical affairs teams.
• Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards.
• Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
• Oversee and manager external CROs and vendors to ensure high-quality and timely deliverables.
• Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making.

Must-Haves:

• Associate Director: PhD with 6+ years or MS with 9+ years of biostatistics experience
  • Director: PhD with 9+ years or MS with 12+ years of biostatistics experience
• CNS therapeutic area experience is a plus
• Skilled in scientific programming including SAS or R, or Python for data analysis, graphing, and simulation
• Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH)
• Extensive knowledge with CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting
• Ability to communicate complex statistical concepts clearly to non-statistical audiences.
• Ability to manage multiple projects in a fast-paced environment, flexibility to adapt to changing priorities and timelines
• Ability to effectively collaborate with internal stakeholders and manage the statistical work of external stakeholders/vendors

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $190,000-$220,000 for the Associate Director level and $230,000-$250,000 for the Director level. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

This role has the ability to be fully remote. If you are located in the Boston area, we prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

The Opportunity

If you've worked alongside hardware teams, you know the damage that results from a missed change request or critical context that was never relayed to the right person. Reflow exists to close that gap. We're building the first AI-powered platform purpose-built for hardware product development, one that listens across the tools teams already use, maintains a structured picture of every program, and proactively coordinates across disciplines when things inevitably change.

This is a ground-floor opportunity for a hands-on frontend engineer to shape the user experience of a high-potential product with the support of a parent company leading innovation in engineering and manufacturing.

Who We're Looking For

We're seeking a frontend engineer who cares deeply about building interfaces that are fast, intuitive, and delightful. The ideal candidate has shipped production React applications and has strong opinions on component architecture and design systems. You should already be using AI coding tools like Cursor, Copilot, or Claude to accelerate your work, with excitement about building the product that finally replaces the spreadsheets and status meetings that hardware teams have been stuck with for decades.

This senior engineer will work alongside our engineering team and head of product to build the interfaces through which users manage structured engineering artifacts (requirements, project plans, dependencies), interact with ambient AI agents, and get real-time transparency into project health across disciplines. The role is hands-on - you will be coding daily while contributing to frontend architecture decisions and helping grow the design system as we scale.

What You'll Do

Your day-to-day responsibilities will include:

● Building production-grade React applications with TypeScript

● Developing and maintaining a shared component library

● Building rich interfaces for structured engineering data: requirements with traceability, phase/gate tracking, dependency graphs, task boards with discipline tags, and version-controlled project plans

● Building interfaces for AI agent interactions including streaming chat, proactive coordination alerts, and AI-generated status summaries and deliverables (proposals, SOWs, reports)

● Implementing portfolio-level dashboards for engineering leaders and executives showing cross-project cost, schedule, and risk

● Writing well-tested code with unit and end-to-end tests

● Collaborating with backend engineers on API integration and client SDK usage

● Contributing to frontend architecture decisions, code reviews, and engineering best practices

Technical Requirements

Must Have:

● 5+ years building production web applications, with 3+ years focused on React

● Demonstrated proficiency using AI coding tools (Cursor, Copilot, Claude, etc.) to accelerate development

● Expert-level expertise with React, TypeScript, and modern JavaScript

● Strong experience with component-driven development, design systems, and tools like Storybook

● Proficiency with CSS frameworks (Tailwind CSS preferred) and responsive design

● Experience with modern build tools (Vite, esbuild, or similar)

● Understanding of API integration patterns (REST, OpenAPI, generated clients)

● Ability to balance rapid iteration with maintainable, well-tested code

Highly Valuable:

● Have worked in early-stage 0 to 1 startup environments

● Familiarity with hardware development, engineering workflows, or project management processes

● Experience building UIs for AI/LLM-powered features (streaming responses, chat interfaces, structured AI output)

● Familiarity with headless component libraries (Base UI, Radix, Headless UI)

● Background in data visualization or dashboard-heavy applications

● Understanding of authentication/authorization patterns (OIDC, JWT)

● Experience with end-to-end testing frameworks (Playwright, Cypress)

● Background in B2B SaaS platforms, project management tools, or technical collaboration products

What We Offer

Real Impact: The opportunity to build purpose-built tooling for an entire industry that has never had it

Customer Access: Direct exposure to hundreds of real hardware projects annually through Re:Build's engineering and manufacturing companies

Technical Growth: Hands-on work with cutting-edge AI technologies solving novel technical challenges

Autonomy: Backed by Re:Build while operating with startup independence

Benefits: Full health/dental/vision, bonus program, generous 401K, paid time off, annual learning stipend

Equity & Growth: Participation in Re:Build's LTIP equity program and opportunity for founder equity in potential spin-out

Compensation & Location

Location: Remote-first, with preference for candidates in Boston, Seattle, Los Angeles, or other cities with Re:Build offices

Compensation: Base salary range of $165,000 to $215,000 with performance bonus and long-term incentive plan offered. Potential equity stake under independent spinout scenario.

Please note this role is restricted to US citizens or lawful permanent residents only due to exposure to export controlled information

About Re:Build Manufacturing

Re:Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America's next generation industrial company. At Re:Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We harness deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We've assembled a powerful set of complementary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we're using their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products. Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

Re:Build is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at accommodations.ta@ReBuildmanufacturing.com or you may call us at 617.909.6275.

Senior Technician

About the Role

We are seeking a top-notch Technician to join QuEra's Hardware Engineering team is. This hands-on role supports a broad range of laboratory, assembly, and technical operations across electrical, mechanical, optical, liquid cooling, and machine shop domains. The ideal candidate is detail-oriented, organized, and comfortable working in a dynamic R&D environment.

Responsibilities:

Electrical

• Assemble and test prototypes.
• Validate and refine assembly/test documentation.
• Assist in creating wiring documentation and diagrams.
• Install and remove modules.
• Package and ship modules.
• Order and track parts.
• Maintain electrical lab spaces—cleanliness, organization, and stock.
• Provide backup support for key personnel

Mechanical / Optical

• Assemble and test mechanical and optical prototypes.
• Create 2D GD&T drawings for parts and assemblies.
• Review and revise assembly and test documentation.
• Modify or repair parts as needed.
• Perform fiber splicing.
• Maintain lab spaces—organization, cleanliness, and consumables.

Liquid Cooling

• Fabricate tubing assemblies, install connectors, and leak-test connections.
• Install tubing and chillers, including setup and integration.
• Monitor and maintain chillers for operational reliability.
• Manage chiller RMAs and shipping.
• Conduct pressure and flow testing of systems.

Machine Shop

• Maintain and service shop tools.
• Ensure the shop is clean and well-stocked with consumables.
• Provide assistance to users on machining projects.
• Conduct mill trainings (upon gaining sufficient expertise).

Qualifications

Required

• Hands-on experience in one or more of the following areas: electrical assembly, mechanical assembly, optical systems, fluid systems, or machining.
• Ability to read technical drawings, wiring diagrams, and assembly instructions.
• Strong organizational and documentation skills.
• Comfort with shipping/receiving, inventory, and lab/shop upkeep.
• Willingness to learn across multiple technical domains.
• Strong communication skills and cooperative spirit

Preferred

• Prior experience in a research, prototyping, or advanced hardware environment.
• Knowledge of fiber splicing, GD&T drawing standards, or liquid cooling systems.
• Familiarity with machining tools and basic mill operation.
• Experience supporting interdisciplinary R&D teams.

The approximate base salary range for this position is $90,000-$125,000.

We consistently monitor external market data and update base salary ranges accordingly.  We determine base compensation decisions on several factors, including as geographic placement, role-specific knowledge, skills, and/or experience.  In addition to our base salary offerings, we also provide equity grants for all new hires.

QuEra is committed to cultivating a diverse work environment and is proud to be an equal opportunity employer. We highly value diversity in our current and future employees and do not discriminate (including in our hiring and promotion practices) based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

Principal Mechanical Engineer

About Us

We are building scalable, fault-tolerant neutral atom quantum computers that harness the power of atomic physics, precision engineering, and advanced control systems. Our interdisciplinary team combines quantum scientists, optical mechanical and electrical engineers, and software developers to push the boundaries of what’s physically possible.

About the Role

We are seeking a Principal Mechanical Engineer to lead the mechanical system design, system engineering, and infrastructure architecture that enable high-fidelity, scalable neutral atom quantum systems. This role will own key aspects of system design and integration — from mechanical and thermal stability to automated alignment and digital design workflows — ensuring that our hardware meets the demands of world-class quantum performance.

You will be responsible for end-to-end ownership of mechanical design and integration, partnering closely with physics, optical, and controls teams to deliver robust, high-precision, and manufacturable systems.

Key Areas of Ownership

• Thermal and Vibration Management – Architect and own thermal control systems, including liquid cooling infrastructure, vibration isolation, and dynamic stability of quantum system platforms.
• Systems Engineering (SysML) – Apply systems engineering principles and SysML modeling to define interfaces, requirements, and traceability across mechanical, electrical, and optical domains.
• PLM / Digital Thread – Establish and maintain a robust product lifecycle management (PLM) workflows and practices, ensuring a seamless digital thread from concept through production.
• CAD Ownership – Oversee mechanical CAD architecture, standards, libraries, and best practices across the engineering organization.
• DFM/DFA - Ensure smooth transfer of design to NPI at CM by ensuring design and documentation accuracy and completeness (mCAD, BOM, assembly and testing procedures and documentation, etc.).
• Alignment and Calibration Design for Automation – Lead the mechanical and control architecture for automated alignment, calibration, and repeatability across complex opto-mechanical subsystems.
• Precision Engineering – Develop robust, reliable, and stable assemblies supporting optical and electrical requirements.

Responsibilities

• Own the architecture, design, optimization of electrical enclosures, liquid cooling and thermal/environmental control systems, ultra-high vacuum (UHV) chambers, vibration isolation, and precision opto-mechanical assemblies through delegation and mentoring of more junior engineers.
• Communicate clearly and concisely across multidisciplinary teams about technical reasoning and design tradeoffs, project statuses, risks, blockers, etc.
• Collaborate with cross-functional teams (optical engineering, electrical engineering, controls engineering, laser engineering, software engineering, AMO physicists and other scientists) to ensure tight integration and system-level performance and reliability
• Advocate for and help implement engineering best practices including phase-gated design process, testing, and proper documentation to enable reliability and scalability, while also balancing the need to make rapid progress in a fast moving startup environment.
• Contribute strategically to system roadmaps, manufacturing scaling plans, and overall hardware development strategy.
• Advance state-of-the-art engineering practices at QuEra through independent research, problem-solving, and continuous improvement initiatives.
• Coordinate closely with the R&D/science team to clearly define requirements for modules and systems, and to translate those requirements into testable acceptance criteria.

Qualifications

Required:

• M.S. or Ph.D. in Mechanical Engineering or related field, or equivalent experience.
• 10+ years in precision mechanical design for high-stability or opto-mechanical systems.
• Expertise in thermal management, vibration isolation, and liquid cooling systems.
• Strong proficiency in CAD tools (e.g., SolidWorks or Inventor), PLM and digital thread practices, and analysis tools.
• Experience implementing systems engineering frameworks (SysML, MBSE).
• Proven success in leading complex, multi-disciplinary hardware development programs from concept through to production
• Collaborative mindset
• Ability to move fast and keep multiple projects moving forward at the same time

Preferred:

• Background in atomic physics, quantum systems, or UHV opto-mechanical design.
• Experience developing and scaling automation systems for precision alignment or calibration.
• Hands-on experience with precision assembly, metrology, and validation testing.
• Proven track record of taking design from concept through NPI and into sustainment
• Strong communication and leadership skills across technical and executive teams.

Salary Range: 150,000 - 210,000. We consistently monitor external market data and update base salary ranges accordingly.  We determine base compensation decisions on several factors, including as geographic placement, role-specific knowledge, skills, and/or experience.  In addition to our base salary offerings, we also provide equity grants for all new hires.

QuEra is committed to cultivating a diverse work environment and is proud to be an equal opportunity employer. We highly value diversity in our current and future employees and do not discriminate (including in our hiring and promotion practices) based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

Mechanical Engineer 

Position Overview

QuEra is seeking a Mechanical Engineer with expertise and experience in manufacturing to join our growing team building next-generation neutral atom quantum computers. This individual will work collaboratively with other engineers and the supply chain team to facilitate smooth new product introductions (NPIs) by ensuring documentation packages are accurate, complete and ready to transfer to suppliers and contract manufacturing partners. You will bridge the gap between design engineering and fabrication, ensuring that technical specifications and production requirements are properly communicated to vendors.

The ideal candidate will have a foundation in mechanical design principles, proficiency with 3D modeling tools (Autodesk Inventor preferred), strong experience in design for manufacturing and assembly (DfM/DfA), knowledge of GD&T, and experience working with machine shops and contract manufacturers.

Key Responsibilities

• Ensure documentation packages are accurate, complete and ready to transfer to suppliers and contract manufacturing partners
• Update existing designs and drawings, conduct design for manufacturing/assembly (DFM/DFA) reviews, and maintain documentation for customized products
• Author and maintain assembly and inspection procedures related to the manufacture of mechanical, electro-mechanical and opto-mechanical modules and sub-assemblies
• Change management and product structure management within CAD and product lifecycle management (PLM) tools
• Maintain QuEra’s technical drawing standards and support the design engineering team to execute changes to drawings as required
• Release technical documentation packages to external vendors and coordinate CAD file conversions
• Interact with suppliers to troubleshoot production issues, and maintain design and manufacturing documentation for improvements
• Ensure BOMs are properly structured and BOM data is accurate for procurement and collaborate with sourcing teams to resolve supplier discrepancies
• Design of modules as needed

Qualifications

• Bachelor’s degree in Mechanical Engineering or a related field
• Minimum 3 years of professional experience in mechanical design and creating manufacturing documentation packages in support of outsourcing production
• Proficiency in 3D CAD software (preferably Inventor) and experience using PDM software (preferably Autodesk Vault)
• Thorough understanding of fabrication, machining, sheet metal, and electromechanical and/or optomechanical assembly techniques
• Proficiency with product lifecycle management (PLM) and configuration management processes (ECO/ECR/MCO)
• Excellent problem-solving skills
• Strong written and verbal communication skills, and the ability to work collaboratively with internal and external stakeholders

Preferred Qualifications

• Experience in optical systems and/or electronic systems manufacturing environments
• Experience with prototype fabrication and testing
• Familiarity with digital thread and model-based definition (MBD) environments
• Previous experience working in a startup environment

Salary Range: 125,000 - 160,000. We consistently monitor external market data and update base salary ranges accordingly.  We determine base compensation decisions on several factors, including as geographic placement, role-specific knowledge, skills, and/or experience.  In addition to our base salary offerings, we also provide equity grants for all new hires.

QuEra is committed to cultivating a diverse work environment and is proud to be an equal opportunity employer. We highly value diversity in our current and future employees and do not discriminate (including in our hiring and promotion practices) based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

We’re looking for a Temporary Assembly Technician to help us build the next generation of our 3D printers. This is a unique, hands-on role where you’ll get to assemble prototype printers, tools, and systems—directly supporting our hardware development team.

If you’re someone who loves working with your hands, learning new skills, and being part of a team that brings cutting-edge technology to life, this is the opportunity for you.

What You’ll Do:

• Assist in assembling prototypes of next generations 3D printers, fixtures and accessory equipment
• Assemble and pack out products following specific procedures.
• Responsible for the accuracy of work-in-process.
• Responsible for the cleanliness of the work area and surrounding work space.
• Ability to use various hand tools (pliers, rulers, cutters, torque wrenches and screwdrivers)
• Verify the material's condition before putting it together and report any problems.
• Other responsibilities as directed and necessary for the business.

About You:

• High School diploma or equivalent education, technical training a plus.
• Capable of performing job function utilizing written procedures, verbal instructions and visual aids.
• 1 + years electro-mechanical assembly in the manufacturing industry.
• Ability to read assembly procedures and follow visual aids.
• Basic knowledge of manufacturing processes.
• Basic mechanical assembly knowledge.
• Basic computer skills.
• Good organizational skills.
• Ability to work and communicate effectively in a lean team environment.
• Ability to lift 50+ pounds frequently throughout the day 

Bonus Skills (not required, but great to have):

• Ability to read, understand, and interpret mechanical, electrical, and electronic schematic drawings and diagrams
• Fabrication and hand soldering experience
• Electrical wiring skills are a plus

Job Details

• Schedule: Full-time, Mon–Fri, 9:00am–5:00pm (hourly; schedule may flex with business needs)
• Duration: March through May (temporary role)

Our Perks:

• Free onsite parking
• Catered healthy lunches 3x per week + snacks, drinks, and treats
• Unlimited 3D printing (yes, really!)
• A chance to get hands-on with the coolest 3D printing tech out there

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.  

Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

Senior Optical Engineer

The Hardware Engineering Group at QuEra Computing is seeking strong candidates for a Senior Optical Engineer to serve as a senior individual contributor to the company’s mission of building state-of-the-art, manufacturable, and deployable neutral atom quantum computers. The Hardware Engineering Group plays a crucial role in accelerating the company’s technology leadership and translating the company’s scientific breakthroughs into products delivered to customers. To accomplish this mission, we are looking to hire a candidate with graduate-level education in optics, optical engineering, or applied physics with industry experience in an enterprise engineering environment. The ideal candidate will combine a deep, fundamental understanding of several areas of optics, design, and engineering. Although candidates with a Ph.D. in physics may be considered, applicants should ensure they have sufficient professional experience beyond academia in an enterprise engineering environment to establish themselves independently as a senior-level engineer.

Key Job Responsibilities

• Work with physicists to understand requirements and architect optical systems, sub-systems, modules, and components to support QuEra’s neutral atom computers through the full development lifecycle (R&D, productization, maintenance, and beyond).
• Advance state-of-the-art engineering practices at QuEra through independent research, problem-solving, and continuous improvement initiatives.
• Coordinate closely with the R&D/science team to enable cutting-edge R&D and translate scientific advances into the next generation of products.
• Troubleshoot technical issues at company headquarters and off-site installations at customer locations (in coordination with local support team).

Qualifications

• B.S. in optics, optical engineering, applied physics, or a closely related field (Ph.D. or M.S. preferred).
• 5-8 years work experience designing optical and opto-mechanical systems in a non-academic (industry, national lab, FFRDC or similar) environment with enterprise engineering practices.
• Excellent system-level design skills including Zemax simulation skills, COMSOL simulation skills, and CAD design skills, etc.
• Deep domain expertise in the areas of
• Free-space optics (free-space and fiber)
• Modulators
• Electronics
• Lasers
• Optical system characterization and testing
• Ultra-high vacuum
• Strong hands-on laboratory skills (e.g. assembly, alignment, cleaning, testing)
• Experience leading the design of scientific instruments and apparatuses and bringing complex optical systems from concept to production.

We consistently monitor external market data and update base salary ranges accordingly.  We determine base compensation decisions on several factors, including as geographic placement, role-specific knowledge, skills, and/or experience.  In addition to our base salary offerings, we also provide equity grants for all new hires.

QuEra is committed to cultivating a diverse work environment and is proud to be an equal opportunity employer. We highly value diversity in our current and future employees and do not discriminate (including in our hiring and promotion practices) based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

Electrical Manufacturing Engineer

Boston, MA USA

Electrical Engineer 

Position Overview

QuEra is seeking an Electrical Engineer with expertise and experience in manufacturing to join our growing team building next-generation neutral atom quantum computers. This individual will work collaboratively with other engineers and the supply chain team to facilitate smooth new product introductions (NPIs) by ensuring documentation packages are accurate, complete and ready to transfer to suppliers and contract manufacturing partners. You will bridge the gap between design engineering and fabrication, ensuring that technical specifications and production requirements are properly communicated to vendors.

The ideal candidate will have a foundation in electrical design principles, proficiency with PCB CAD software (Altium preferred), strong experience in design for manufacturing and assembly (DFM/DFA), knowledge of GD&T, and experience working with PCB fabrication houses (foreign and domestic) and contract manufacturers.

Key Responsibilities

• Ensure documentation packages are accurate, complete and ready to transfer to suppliers and contract manufacturing partners
• Update existing designs and drawings, conduct design for manufacturing/assembly (DFM/DFA) reviews, and maintain documentation for customized products
• Author and maintain assembly and inspection procedures related to the manufacture of analog/RF electrical, power electrical, electro-mechanical modules and sub-assemblies
• Maintain and categorize Corporate Altium Part Managed Library. Create new footprints/symbols for new parts (Parts Librarian).  
• Change management and product structure management within CAD and product lifecycle management (PLM) tools
• Maintain QuEra’s technical drawing standards and support the design engineering team to execute changes to drawings as required
• Release technical documentation packages to external vendors and coordinate CAD file conversions
• Interact with suppliers to troubleshoot production issues, and maintain design and manufacturing documentation for improvements
• Ensure BOMs are properly structured and BOM data is accurate for procurement and collaborate with sourcing teams to resolve supplier discrepancies
• Review schematics, layouts, and BOMs to identify manufacturability risks early
• Influence design decisions to improve yield, reliability, and cost.

Qualifications

• Associates Degree in Electrical Engineering, Electronics or a related field; in lieu of a degree, 6+ years of experience performing the described duties
• Minimum 3 years of professional experience with electrical systems and creating manufacturing documentation packages in support of outsourcing production
• Proficiency in PCB CAD software (preferably Altium).
• Thorough understanding of PCB fabrication, assembly, production test, ICT, flying probe, developing custom test setups. 
• Proficiency with product lifecycle management (PLM) and configuration management processes (ECO/ECR/MCO)
• Excellent problem-solving skills
• Strong written and verbal communication skills, and the ability to work collaboratively with internal and external stakeholders

Preferred Qualifications

• Experience in FCC/UL/CE and General Compliance Testing
• Experience with prototype fabrication and testing
• Familiarity with digital thread and model-based definition (MBD) environments
• Previous experience working in a startup environment

QuEra is committed to cultivating a diverse work environment and is proud to be an equal opportunity employer. We highly value diversity in our current and future employees and do not discriminate (including in our hiring and promotion practices) based on race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law.

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

Our passion is designing and building powerful 3D printing tools. Our manufacturing team is responsible for research and development of the manufacturing processes for all of Formlabs products. They work cross functionally with mechanical design, electrical, and materials teams.

If you’re excited to help us design new assembly processes and layouts and to develop and deploy custom tooling and calibration equipment, we want you as a Senior NPI Manufacturing Engineer.

 The Job:

• Create and manage line layouts, standard operating procedures and equipment requirements for complex assemblies by breaking them down into logical parts flow of subassemblies and sub-processes
• Define, develop and manage initial prototype lines for module and system level assembly
• Establish calibration and assembly checks throughout the assembly process to ensure adherence to the design and to catch failures earlier in the process 
• Analyze production lines; define the process and put metrics around it, and then iterate to improve on them 
• Work with contract manufacturers and suppliers who create custom parts and work with them to improve their output
• Communicate with design engineers to propose and then ensure design changes are adopted to improve the manufacturing process 

You:

• 5+ years of manufacturing engineering experience
• Experience working with in house manufacturing and/or contract manufacturers or suppliers.  Bonus for international supplier experience.  
• Proactive problem solver
• Successfully brought electro-mechanical products or projects to market on time and within budget
• Experience defining and evaluating production line performance metrics 
• Have a Bachelor's degree in an applicable engineering field (Mechanical, Electrical, Systems, etc.)

Do you want to change how the world creates?

At Formlabs, we’re building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.

We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to shape the future of fabrication, come build it with us.

If you’re excited to help us develop and deploy calibration equipment and assembly tools, we want you as a Senior Advanced Manufacturing Engineer.

 The Job:

• Improve existing manufacturing lines, helping us grow with our volumes
• Establish in line or intermediate checks to catch failures earlier 
• Design and analyze production lines; build a process and put metrics around it, and improve on them 
• Work with contract manufacturers who create our custom parts and work with them to improve their output
• Communicate with design engineers to ensure design changes are adopted

You:

• 5+ years of manufacturing engineering experience
• Experience working with overseas contract manufacturers or suppliers
• Proactive problem solver
• Successfully brought electro-mechanical products or projects to market on time and within budget
• Experience evaluating production line performance metrics 
• Have a Bachelor's degree in an applicable engineering field (Mechanical, Electrical, Systems, etc.)

Our Perks & Benefits:

• Robust equity program to build future wealth through RSUs
• Comprehensive healthcare coverage (Medical, Dental, Vision)
• Low cost fund options in our 401K and access to advisors 
• Generous paid Parental Leave (up to 16 weeks)
• Tenure-based paid Sabbatical Leave (up to 6 weeks)
• Flexible Out of Office Plan – Take time when you need it
• Ample on-site parking & pre-tax commuter benefits
• Healthy on-site lunches, snacks, beverages, & treats
• Regular sponsored professional development opportunities
• Many opt-in culture events across our diverse community
• And of course… unlimited 3D prints

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.  

Even if you don't check every box, but see yourself contributing, please apply.  Help us build an inclusive community that will change the face of 3D printing.

About Re:Build Manufacturing

Re:Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America’s next generation industrial company. At Re:Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We leverage deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We’ve assembled a powerful set of complimentary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we’re leveraging their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products. Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

Who We Are Looking For:

We are seeking an individual to manage and develop drone component products that bring to bear the breadth of our capabilities.   These efforts are strategic and involve multiple functions, with high commercial value and technical and organizational complexity.   The Product Manager will draw on resources from our innovation, design, engineering, software, manufacturing, and supply chain teams.   They will draw from engineering and operational expertise to assist with customer relationships, marshal internal resources across multiple companies, and foster teamwork between Re:Build companies and clients. As an excellent communicator, the Product Manager is expected to have the foresight to identify and mitigate risks in advance, while balancing multiple, sophisticated programs in parallel.

As the Product Manager for Re:Build’s Drone Thesis, you will own requirements definition, product development, implementation of the manufacturing environment, and the program to achieve our goals. You will be accountable for ensuring that Re:Build delivers world-class drone components, integration, and design that meet the performance, safety, and reliability standards required across commercial, aerospace, government, and industrial sectors.

Reporting to the Drone Thesis Leader, this leadership role combines technical expertise with the ability to execute at a high level. You will guide a multi-disciplinary team through all phases of a program. 

What you get to do

• Manage profit and losses for drone product lines.
• Build and drive product plans from the ground up from initial requirements' statement, through to manufacturing, including developing manufacturing processes and facilities. 
• Lead product feasibility studies, technology development, product development, and transition to manufacturing for sophisticated products. 
• Partner with commercial market leads and finance leaders to develop market and customer financial assessments. 
• Assess financial models to ensure product pricing to ensure products are mutually beneficial for customers and Re:Build  
• Work across teams to identify project dependencies and build out detailed development cycle timelines. 
• Drive programs to completion while ensuring that the budget, resource, and timeline constraints are maintained. 
• Facilitate creative solutions to unanticipated events and unforeseen demands to ensure on-time delivery. 
• Facilitate regular communication between the client and site leads, and communication of project status to Re:Build leadership. 
• Assist with internal process development and standardization for product deployments. 
• Coordinate and track product certification efforts with regulatory bodies as needed. 
• Facilitate iterative product cost down efforts. 

What you bring to the Team

• BS degree in an engineering or technical field (electrical, mechanical, or manufacturing engineering), or equivalent experience.   Advanced technical degree preferred. 
• Seven+ years of full-time work experience in product engineering and/or manufacturing environments, including two+ years managing teams as a product manager or functional manager.  
• Experience in drone product development and/or manufacturing preferred.
• A proven ability to influence others to work cooperatively and meet deadlines without having direct line supervisory responsibility. 
• Demonstrated success bringing technically complex programs or products to completion on-time and on-budget while providing exceptional service to customers. 
• Experience managing timelines, requirements, budgets, and metrics for technically complex products for commercial customers. 
• Experience handling timeframes for products subjected to regulatory certification like UL, CE, CSA, FAA etc. 
• Demonstrated ability to navigate supply chains for ordering processes and the associated lead times. 
• Certifications in Program and/or Project Management preferred. 
• Experience using project management tools like Smartsheet, MS Project, ClickUp, Asana, Confluence (or equivalent). 
• Experience using PDM or PLM systems as part of an engineering role. 

This role will require up to 20% travel. 

The preferred location for this role is Framingham, MA.

Compensation Range: Annual salary for this position is expected to be between $143,000 to $180,000 plus participation in our annual bonus plan and long term incentive plan. The actual pay may be higher depending on your qualifications and experience. 

Export Control Requirement: Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.

The BIG payoff

We are a company who is going to make a difference in the industries and the regions where we choose to operate. Every employee of Re:Build will share ownership in the company and will share in the financial rewards of the success we achieve together, at all levels of the company!

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

Your Impact:

The Director of Regulatory Strategy will play a pivotal role in leading strategic regulatory initiatives for assigned drug development programs.

Your Day-to-Day:

• Create and implement innovative and effective regulatory strategies to support the development of Rapport global drug development programs
• Provide regulatory expertise and advise to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical
• Accountable for the maintenance of regulatory applications such as INDs, CTAs, NDAs, etc.
• Identify regulatory risks and mitigation plans
• Serve as the regulatory lead on project teams
• Ensure compliance with local and international submission requirements, manage CROs as applicable.
• Represents Rapport as the point of contact for regulatory health authorities, as assigned ensuring exemplary ethics and transparency within the company and with health authorities
• Keeps current with global regulatory landscape and advises project teams on potential impact to programs
• Provide mentorship and support to junior team members to foster their professional growth and development

Must-Haves:

• Bachelors degree in a life science or related discipline
• 12+ years of experience in the pharmaceutical or biotech industry
• Experience in neurology and small molecules preferred
• Global drug development experience
• Experience working with DAAP or Neurology FDA Divisions
• Ability to manage competing priorities, influence and integrate within a team, manage timelines and deliver on corporate and program goals.
• Strong interpersonal skills and alignment with Rapport’s values and company culture
• Must demonstrate strong leadership and team building skills, including experience with conflict resolution and real time problem solving.
• Thorough understanding of the development phases within a fast-moving biopharmaceutical organization.
• Exceptional written and verbal communication skills

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $220,000 to $240,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Position Summary

We are seeking a Lead Scientist to drive the evolution of Ginkgo’s automated antibody production and developability platforms. This role is pivotal in bridging complex antibody engineering, specifically bi- and multi-specific formats, with Ginkgo’s RAC (Reconfigurable Automation Cart) systems. The ideal candidate is a technical expert in antibody transfection, purification, and characterization who thrives on translating manual workflows into robust, automated pipelines.

Key Responsibilities

• Lead method development and execution of antibody production and characterization on Ginkgo’s autonomous robotic labs using the RAC (reconfigurable automation cell) systems.
• Optimize high-throughput transfection and purification protocols for complex modalities, including bi-specifics and multi-specifics, at various scales (96 wp, 24 wp, 6 wp), ensuring high purity and correct assembly.
• Execute and automate standard developability suites (thermal stability, aggregation, polyreactivity, etc), binding assay (BLI, SPR) and functional assays (cell-based) to support rapid "Design-Build-Test" cycles.
• Serve as the project lead for customer projects focused on antibody production and developability characterization.
• Mentor junior scientists and contribute to scientific strategy and innovation.
• Author technical reports, SOPs, and present findings to internal leadership and external customers

Required Qualifications

• Ph.D. in Chemical Engineering, Bioengineering, Molecular Biology, or a related field with 2+ years of industry/academic experience in antibody production and characterization (or M.S. with 6+ years of industry/academic experience).
• Direct experience with the production and purification of complex antibody formats (e.g., bi-specifics, VHH-Fcs). Experience with Protein A/G/L, IEX, and SEC, specifically in a high-throughput or automated context.
• Demonstrated proficiency in antibody binding (SPR, BLI) and developability (DSF, DLS, SEC, HIC, AC-SINS, Polyreactivity, etc.) assays
• Demonstrated proficiency in using automated liquid handlers such as the Lynx, Bravo, TECAN, Hamilton

Preferred Qualifications

• Prior experience onboarding assays onto robotic platforms (e.g., translating a manual SEC-MALS or ELISA to a liquid handler).
• Experience with mass spectrometry (LC-MS) for confirming chain pairing in multi-specific formats.
• Familiarity with Python or scheduling software for automation.

Total compensation for this role is market driven, with a starting salary of $100k+, as well as company stock awards.  Base pay is ultimately determined based on a candidate's skills, expertise, and experience.  We also offer a comprehensive benefits package including medical, dental & vision coverage, health spending accounts, voluntary benefits, leave of absence policies, Employee Assistance Program, 401(k) program with employer contribution, 8 paid holidays in addition to a full-week winter shutdown and unlimited Paid Time Off policy.

Ginkgo has implemented a return to office policy effective October 1, 2025 with required in-office days 3x per week on Tuesday, Wednesday, Thursday.  Some teams may require to be onsite 4-5 days per week and this will be discussed as part of the interview process.  This policy applies to all employees who live within 50 miles of Ginkgo’s offices in Boston, MA, Emeryville, CA and West Sacramento, CA.

Lead Package Assembly Integrator

In this role, you will work on leading-edge packaging technologies to enable AI architectures that set new industry standards for compute power, performance, and efficiency. As part of the Packaging Technology team, you will serve as the lead assembly process integrator. Your responsibilities will include developing assembly process technologies and generating assembly/test design rules for Heterogeneous Integrated co-packaged optics technologies by collaborating with design teams, silicon and photonics foundries, and OSAT partners. You will be responsible for developing test chip strategies, managing test chip design, and appropriately planning and managing design of experiments with partners. Additionally, you will work closely with package and system architects to incorporate manufacturability considerations into product definitions. The results of your work will lead to advanced package designs that meet assembly and reliability requirements, while delivering leading-edge products for data centers and the high-end compute segment.

Responsibilities: 

• Develop end-to-end 3D package assembly, test, and fiber-attach processes for Lightmatter products, ensuring robust high yields while meeting performance and reliability goals by working closely with foundry and OSAT partners.
• Develop and execute package architectures and designs, ensuring they meet rigorous product performance standards while optimizing for manufacturability and long-term reliability.
• Define test chip requirements and manage test chip design required for 3D package process development.
• Develop and validate design rules for a high-yielding assembly process. The scope includes assembly/test, backend/RDL, silicon/package interaction, substrate, thermal/mechanical solutions, fiber attach, system integration, and other related areas.
• Plan and execute design of experiments, manage data, and perform appropriate analysis to gain insights into assembly process and design interactions.
• Perform analysis to identify key reliability risks under product use conditions and drive appropriate design and materials solutions to improve product mechanical integrity.
• Summarize and communicate to key stakeholders across Lightmatter, suppliers and customers as required.
• Write reports and document methodologies.

Required Qualifications:

• MS or PhD in Mechanical Engineering, Material Science, or related engineering field.
• 10-12 years of experience in wafer scale packaging assembly process development.
• Knowledge of 2D/3D packaging technologies, materials, and equipment requirements.
• Proven ability to define requirements for test chip and assembly test vehicles.
• Understanding of photonics packaging requirements including various fiber attach methods.
• Experience with advanced packaging technologies, including thermal, mechanical, and reliability factors.

Preferred Qualifications:

• Excellent communication skills, with the ability to convey complex technical concepts to both technical and non-technical stakeholders.
• Strong project ownership, with a history of driving results independently and with minimal supervision.
• Proven track record of developing creative solutions for complex technical challenges.
• Experience in thermal and mechanical modeling and coding for data analysis.

About this Role