Global Device Risk & Post-Market Quality Engineer

BioSpace; Cambridge (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Sanofi Inc. in Cambridge, MA is seeking a Device Quality Engineer to lead risk management, clinical evaluation, and post-market surveillance across the global device portfolio.

You will ensure compliance with ISO 14971, MDR, and related regulatory requirements throughout the product lifecycle. You will partner with quality, compliance, development, and manufacturing teams to deliver expert evaluations, drive improvements, and mentor colleagues in risk management methodologies while supporting

Qualifications

• BS degree in Engineering, Business, Life Sciences or related discipline.
• MS degree is a plus.
• 5+ years of medical device industry experience.
• 3+ years in Risk Management and Post-Market Surveillance.
• Knowledge of ISO 14971, ISO 13485, MDR, and 21 CFR 820.
• Experience in complaint handling is a plus.
• English required; French or German a plus.

Responsibilities

• Lead Device Risk Management, Clinical Evaluation, and PMS globally.
• Ensure SOPs meet regulations while driving improvements.
• Analyze post-market data to identify trends and take corrective actions.
• Maintain Device Risk Management Files reflecting current product risks.
• Develop training programs and mentor colleagues on risk management.
• Ensure use of risk tools (FMEAs, PHA) and moderate dFMEA.
• Author post-market surveillance deliverables through product lifecycle.
• Support Design Controls and DHF maintenance in new development.
• Collaborate with quality, compliance, development, and manufacturing teams.

Skills

Risk Management

Post-Market Surveillance

Regulatory Knowledge

ISO 14971

Cross-functional Collaboration

Problem Solving

Education

Bachelor's in Engineering or related field

Master's degree preferred

Job description

Sanofi Inc. in Cambridge, MA is seeking a Device Quality Engineer to lead risk management, clinical evaluation, and post-market surveillance across the global device portfolio.

You will ensure compliance with ISO 14971, MDR, and related regulatory requirements throughout the product lifecycle. You will partner with quality, compliance, development, and manufacturing teams to deliver expert evaluations, drive improvements, and mentor colleagues in risk management methodologies while supporting