Senior Product Safety and Compliance Engineer- Medical Devices
$92,200–$141,400 year
On-site · Needham, Massachusetts, United States
Job Summary
Lead certification projects for medical devices from concept to mass production, managing regulatory filings (FDA 510(k), Technical Documentation/Design Dossiers), and coordinating with Notified Bodies and FDA. Perform risk management per ISO 14971, ensure compliance with ISO 13485, IEC 60601-1, IEC 62304, IEC 62366, and EU MDR 2017/745. Provide SME guidance on biocompatibility (ISO 10993), software lifecycle (IEC 62304), and home healthcare electrical safety (IEC 60601-1-11). Lead cross-functional teams, mentor junior staff, and influence regulatory strategy across global markets. Maintain Design History Files and support post-market surveillance and complaint handling per 21 CFR Part 803. Adapt to evolving regulatory guidance and new product categories, delivering clear, technically sound regulatory solutions to complex problems.
Required Qualifications
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline
- Minimum 5+ years of compliance or design-related experience with consumer, commercial, or medical electromechanical products
- Familiarity with medical device regulatory standards including IEC 60601-1, ISO 14971, ISO 13485, IEC 62304, IEC 62366, ISO 10993, 21 CFR Part 820, EU MDR 2017/745
- Experience interfacing with FDA, Notified Bodies, or accredited test laboratories preferred
- Must be able to operate in a fast-paced environment with regularly shifting priorities
- Strong communication and mentoring skills
- Regulatory pathway knowledge for United States and international markets
- Experience with DFMEA and risk management documentation
- Bachelor's degree in a related field; RAC certification a plus.
Desired Qualifications
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or related field
- RAC certification a plus
- Minimum 5+ years of compliance or design-related experience with consumer, commercial, or medical electromechanical products
- Experience with medical device regulatory standards (ISO 13485, IEC 60601-1, ISO 14971, IEC 62304, ISO 10993, 21 CFR 820, EU MDR 2017/745)
- Familiarity with FDA/Notified Bodies/test laboratories
- Strong analytical, communication, and project leadership skills
- Ability to operate in fast-paced environments with shifting priorities
- Regulatory filing experience (FDA 510(k), Design History Files)
- Biocompatibility and software lifecycle knowledge (IEC 62304, ISO 10993)
- Home healthcare electrical safety experience (IEC 60601-1-11)
- Post-market surveillance and complaint handling knowledge (21 CFR Part 803)
- Leadership and mentoring capabilities
- Regulatory strategy planning and risk management (ISO 14971)
- Ability to work with cross-functional teams and external partners
- Notified Body coordination experience
- US/EU regulatory knowledge
- Home healthcare product certification experience
- Risk management (DFMEA) experience
- Auditing and continuous improvement mindset
- Strong comprehension of medical device regulations for key markets (Health Canada, TGA, ANVISA)
- Regulatory filings and technical documentation preparation
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