Job Title: Senior Design Engineer
Location: Cambridge, MA
About the Job
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.
You serve as a crucial member of the Global Device Platform Engineering Team, taking responsibility for ensuring robust device design and successful delivery of Drug Device Combination Products and Medical Devices.
Working within strict technical, scientific, and regulatory frameworks, you manage development projects to meet established timelines and budgets.
You provide technical leadership and coordination while collaborating closely with cross-functional teams and interacting with Global Device / Quality Leadership Teams and other senior leaders.
You also contribute expertise to optimize the device design for manufacturing efficiency and user experience, while responding to market trends or new standards requirements. Your specialized knowledge in Autoinjector Platform Design and Evaluation supports both - new product development and lifecycle management of marketed products.
Through active participation in the Design Control Process, you maintain essential relationships with both - internal departments and external stakeholders to ensure overall product success.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities
Develops medical devices and drug device combination products following regulatory requirements (FDA, EU MDR) and standards (ISO, IEC)
Acts as a systems engineer for both new drug device combination product development and enhancement of existing platforms. Ensures seamless integration of all product elements including drug formulation, primary container, delivery device, manufacturing processes, testing, labelling and packaging solutions
Maintains the design of medical devices and drug device combination products in lifecycle management
Provides technical leadership to interdisciplinary teams (Design, Quality, Process Engineers, etc.) and coordinates technical tasks with Project / Product Core Teams
Creates and maintains Autoinjector Platform & device design documentation (CAD data, dFMEA, technical specifications)
Plans and maintains design verification activities and documentation (including evaluation and interpretation of test results)
Contributes to change control and event processes as Autoinjector Platform Design Expert
About You
Education & Experience
BS - Engineering, or related field, with a focus on mechanical engineering, plastics engineering, medical engineering or similar - required.
Professional working experience 7+ years in medical device or combination product development, industrialization or manufacturing - required.
Experience in leading of development projects and technical management of interdisciplinary development teams
At least 2+ years of experience with regulatory agencies (e.g. EMA, FDA or TUEV) and key regulatory requirements in the industry (such as DIN and ISO) - required.
Experienced and qualified in project management activities (e.g. PMP)
Confident attitude, committed and used to working independently
Excellent contact and teamwork skills
Languages
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.
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.
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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.
