Global Device Quality Engineer - Risk Management & PMS Lead

Sanofi; Cambridge (MA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health benefits

14 weeks parental leave

Job summary

Sanofi seeks a Device Quality Engineer to lead risk management and post-market surveillance for medical devices and drug-device combinations. You will oversee global processes, ensure ISO 14971 compliance, and collaborate with cross-functional teams to safeguard patient safety across the product lifecycle.

Responsibilities include driving continuous improvement, maintaining DHF, and guiding teams in risk analysis tools.

Qualifications

• BS degree in Engineering, Life Sciences or related science discipline.
• MS degree is a plus.
• 5+ years of medical device industry experience.
• 3+ years in Risk Management and Post-Market Surveillance for medical devices or drug-device combos.
• English mandatory; French or German a plus.

Responsibilities

• Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes globally.
• Ensure SOPs comply with regulations and drive improvements.
• Analyze post-market data to identify trends and implement corrective actions.
• Maintain Device Risk Management Files reflecting current risks throughout the lifecycle.

Skills

Risk Management

Post-Market Surveillance

FMEA

Regulatory Compliance

Cross-functional Collaboration

Education

BS in Engineering or Life Sciences

MS degree preferred

Tools

FMEA Tools

Regulatory Documentation Tools

Job description

Sanofi seeks a Device Quality Engineer to lead risk management and post-market surveillance for medical devices and drug-device combinations. You will oversee global processes, ensure ISO 14971 compliance, and collaborate with cross-functional teams to safeguard patient safety across the product lifecycle.

Responsibilities include driving continuous improvement, maintaining DHF, and guiding teams in risk analysis tools.