Device Quality Engineer - Device Risk Management and Surveillance Excellence

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

Job Title: Device Quality Engineer - Device Risk Management and Surveillance Excellence

Location: Cambridge, MA

About The Job

As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle.

You will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management. The role involves collaborating with cross-functional teams and external stakeholders to ensure expert evaluations on patient safety and compliance matters.

About Sanofi

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main Responsibilities

• Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes across Sanofi as the global process owner
• Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement initiatives
• Analyze post-market data to identify trends, multi-site impacts, and implement corrective actions
• Ensure Device Risk Management Files accurately reflect current product risks and remain updated throughout the product lifecycleProvide guidance on harmonized risk management approaches aligned with ISO 14971 across all development and lifecycle management programs
• Develop new tools, comprehensive training programs and mentor colleagues on process execution, best practices, and risk management methodologies
• Ensure project teams utilize appropriate risk analysis tools (FMEAs, PHA) and facilitate dFMEA moderation sessions
• Author and maintain post market surveillance deliverables throughout the product lifecycle
• Support Design Controls implementation for new product development and design changes, including Design History File maintenance
• Partner with quality, compliance, development, and manufacturing teams to ensure transparency, coordination, and patient safety actions

About You

Basic 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 in Risk Management and Post-Market Surveillance for medical devices and/or drug-device combination products.
• Ability to collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results; knowledge in problem solving methodologies; deep knowledge of ISO 14971. Knowledge of ISO 13485, MDR (2017/745) and 21 CFR 820
• Experience in complaint management a plus
• Languages: Mandatory English management for Business (written and oral) French or German are a plus.

Technical Skills

• ISO 14971 Risk Management
• Post-Market Surveillance (PMS)
• FMEA / Risk Analysis Tools
• Regulatory Compliance (MDR / 21 CFR 820)
• Design Controls & DHF Management

Soft Skills

• Cross-functional Collaboration
• Strategic Thinking
• Attention to Detail
• Stakeholder Influence
• Mentoring & Knowledge Transfer

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellbeing programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff… committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.