Device Quality Engineer - Device Risk Management and Surveillance Excellence
$90,000–$130,000 year
On-site · Cambridge, Massachusetts, United States
Job Summary
Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes across Sanofi's global device programs, ensuring ISO 14971 compliance and regulatory alignment (MDR, ISO 13485, 21 CFR 820). Develop and maintain risk management files, guide harmonized risk management approaches, analyze post-market data for trends, implement corrective actions, and provide training and mentorship on risk analysis tools (FMEAs, PHA) and design controls. Collaborate with cross-functional teams to ensure patient safety actions throughout product lifecycle, including post-market surveillance deliverables and DHF management.
Required Qualifications
- BS degree in Engineering, Business, Life Sciences or related science discipline.
- MS degree is a plus
- 5+ years of medical device industry experience.
- 3+ years of relevant experience in Risk Management and Post-Market Surveillance for medical devices and/or drug-device combination products.
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