Device Quality Engineer - Device Risk Management And Surveillance Excellence
Sanofi Genzyme
Cambridge, MA, US
Base: $90,000 - $130,000; bonus/equity: not specif...
5+ years medical device industry experience
3+ years risk management and pms experience
Deep knowledge of iso 14971
This role serves as the global process owner for Device Risk Management, Clinical Evaluation, and Post-Market Surveillance across Sanofi's Global Device and Packaging Unit
Job Summary
This role serves as the global process owner for Device Risk Management, Clinical Evaluation, and Post-Market Surveillance across Sanofi's Global Device and Packaging Unit.
The position requires ensuring all medical devices and drug-device combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle.
Sanofi offers a thoughtful rewards package including high-quality healthcare, prevention programs, and at least 14 weeks of gender-neutral parental leave.
Matching Summary
This role serves as the global process owner for Device Risk Management, Clinical Evaluation, and Post-Market Surveillance across Sanofi's Global Device and Packaging Unit.
Salary
Base: $90,000 - $130,000; Bonus/Equity: Not specified; Benefits: Eligible for Company employee benefit programs
Skills & Requirements
Must-have
5+ years medical device industry experience
3+ years risk management and PMS experience
Deep knowledge of ISO 14971
Experience with MDR and 21 CFR 820 regulations
Proficiency in FMEA and risk analysis tools
Nice-to-have
MS degree in Engineering or Life Sciences
Experience in complaint management
French or German language skills
Mentoring and training capabilities
Strategic thinking and stakeholder influence
Key Requirements
BS degree in Engineering, Business, or Life Sciences
5+ years of medical device industry experience
3+ years in Risk Management and Post-Market Surveillance