Assistant Biomedical Engineer Jobs in Boston, MA

Senior Product Safety & Compliance Engineer - Medical Devices

NPD Compliance - Medical Devices & Consumer Products

The Senior Product Safety & Compliance Engineer partners directly with global product development teams and certification partners on all aspects of regulatory compliance and product certification. This is a senior, high-ownership role: you will lead multiple certification projects from product concept to mass production, ensure all market access requirements are met, and drive product designs to incorporate appropriate risk mitigation. The role spans FDA-regulated medical devices and products subject to EU MDR 2017/745 alongside our consumer and commercial portfolio and includes mentoring junior engineers.

• Own certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745.
• Lead preparation of regulatory filings - FDA 510(k) submissions and Technical Files/Design Dossiers - and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485.
• Partner day-to-day with Engineering, Quality, Industrial Design, Supply Chain, and Marketing to align regulatory strategy with program goals, translating complex requirements into actionable guidance for design engineers and product managers.
• Own certification timelines, test lab capacity, sample plans and builds, and certification budgets across simultaneous consumer and regulated-device programs, escalating resource conflicts early.
• Establish project needs and deliverables for product development teams and third-party partners, including Notified Bodies and FDA-accredited testing laboratories.
• Execute risk management per ISO 14971 - hazard identification, risk estimation and evaluation, and residual risk documentation across the product lifecycle.
• Drive usability engineering per IEC 62366-1, including formative and summative evaluation planning for devices intended for home healthcare environments.
• Lead weekly project reviews with decision-ready materials covering status, certification timelines, and Notified Body or FDA feedback cycles.
• Serve as subject matter expert on biocompatibility (ISO 10993), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601-1-11), and lead post-market surveillance and complaint handling under 21 CFR Part 803 and EU MDR.
• Mentor junior team members on consumer product certification and medical device regulatory frameworks.

• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Systems, Materials, or a related engineering discipline); RAC certification a plus. An engineering degree is a firm requirement for this role.
• Hands-on experience on the design side of both product design and certification: you have taken electromechanical products through agency evaluation and regulatory submission from concept to production - not solely in documentation, auditing, or quality-records roles.
• Minimum 5+ years of compliance or design experience with consumer, commercial, or medical electromechanical products.
• Strong working knowledge of medical device regulatory standards, including:
  • IEC 60601-1 and applicable collateral/particular standards (esp. IEC 60601-1-2 EMC, IEC 60601-1-6 usability, IEC 60601-1-11 home healthcare environments)
  • ISO 14971 - Risk Management; ISO 13485 - Quality Management Systems
  • IEC 62366-1 - Usability Engineering; IEC 62304 - Software Lifecycle (where applicable)
  • ISO 10993 series - Biocompatibility Evaluation
  • 21 CFR Part 820 - FDA Quality System Regulation
  • EU MDR 2017/745 - classification rules, Technical Documentation, and UDI obligations
  • FDA 510(k) submission processes
• Experience with DFMEA and medical-grade risk management documentation (hazard analysis, risk control verification, residual risk justification).

• Experience interfacing directly with FDA, Notified Bodies, or accredited test laboratories.
• Familiarity with international medical device regulations for key markets (Health Canada, TGA Australia, ANVISA Brazil).
• Discipline-specific depth: Biomedical (ISO 10993, clinical evaluation), Systems (ISO 14971, design controls), Materials (REACH/RoHS, biocompatibility), or Software (IEC 62304, embedded systems compliance).

• A strong cross-functional communicator: you build working relationships across Engineering, Quality, Industrial Design, Supply Chain, and Marketing, and present complex regulatory information confidently at all levels.
• Well-organized and detail-driven: you produce submission-quality documentation and keep traceable records across concurrent workstreams without letting submission status, design-change impacts, or agency action items slip.
• Strong at managing time and resources: you sequence certification work against program gates, use lab and sample capacity efficiently, and flag schedule risk before it becomes a program delay.
• Self-driven and adaptable: you operate with moderate supervision, set priorities across concurrent programs, and thrive in a fast-paced environment with shifting priorities and evolving regulatory guidance.
• Principled under pressure: you hold firm on safety and compliance positions when program timelines are tight, and you collaborate and find workable paths forward where the standards allow - without compromising on safety.
• A problem-solver: you offer technically sound solutions to complex problems including ambiguous regulatory pathway questions - using benefit-risk trade-offs under ISO 14971.
• An owner: you want the ball - and the "last shot of the game" mentality to go with it.