Device Quality Engineer - Device Risk Management and Surveillance Excellence

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 it's 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 wellness 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 Affirmative Action employers 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. #GD-SA #LI-SA #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. North America Applicants Only The salary range for this position is: $90.000,00 - $130.000,00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube