Senior Design Engineer

Location: Cambridge, MA, Bridgewater, NJ

The strategic vision of Sanofi’s Global Medical Device and Packaging organization is to lead the industry in device-mediated therapies, with the ambition to develop, launch and maintain best-in-class drug-delivery systems and connected medical devices that address patient unmet needs and improve health outcomes. Our specific mission is to support R&D and the Sanofi Commercial Business Units by delivering differentiated technology solutions that enhance the value of our drugs and vaccines and help patients (and health care providers) facilitate administration, thereby improving their quality of life and empowering them to take control of their disease. Our products and solutions sit on top of our market leading technology platforms, are user-centric, innovative, environmentally sustainable, producible in high quantities and are continuously improved to meet evolving needs.

The Senior Design Engineer is an integral part of a cross-functional team within the Global Device & Packaging Unit within Sanofi’s Manufacturing and Supply organization. The incumbent will ensure device design technology robustness is implemented into platform device(s) and drug-device combination products(s) as well as provide technical support to commercially released combination products and medical devices (drug delivery systems) according to rigorous technical, scientific and regulatory standards.

The Senior Design Engineer operates within and contributes across ALL medical device lifecycles including early-stage innovation, Design/Development Programs as well as Sustaining Engineering (Product /Platform LCM projects). This individual works within a cross functional team and is responsible for leading device design technology and documentation initiatives required within the domain of the respective lifecycle phase.

The Senior Design Engineer is primarily responsible for creating and maintaining the mechanical design technology of devices and platforms utilized within the GDPU. Several key areas of focus include driving the core product design implementation including optimizations required for best-in-class user centricity, market leadership, environmental sustainability as well as manufacturing efficiency and capacity scale. Specifically, within the LCM/Sustaining Engineering Lifecycle, the Design Engineer serves as the product design technical lead and coordinates/executes PTC (product technical complaints) assessments, coordinates/executes Change Controls as the technical expert and maintains the product design outputs throughout commercial manufacturing of drug-device combination products. 

Sanofi is 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

• Accountable for leading and/or contributing to the technical development of medical device or drug device combination products throughout the late-stage development lifecycle into commercial product maintenance during lifecycle management.

• Responsible for creating, planning and maintaining the Design History File (Design  Verification/Validation activities and documentation during product the maintenance phase, including evaluation and interpretation of test results, excluding laboratory testing execution and raw data handling). 

• Leads, manages and contributes to the creation and maintenance of necessary technical documentation to applicable quality standards, including submissions 

• Technical lead of the mechanical design technology including creating and maintaining platform device & drug-device combination product design specific design output documentation during all phases of the product lifecycle (e.g.: Platform and Device design CAD data 3D & 2D Engineering Drawings, dFMEA, Essential Design Output Summaries, technical design specific specifications, Tolerance Analysis reports, Manufacturing Concepts, etc…).  

• Contributes to Change Control and Event Processes within GDPU and within Site-Network (e.g., as a Platform and Device Design Expert / SME) across of lifecycle(s).

• Responsible for 2nd level PTC processing (deeper level functionality analysis) and 2nd level PTC support (acting as Platform and Device Design Expert / SME) within the sustaining engineering/Product maintenance lifecycle.

About You

Education/Experience:

• Bachelor of Science in engineering or scientific disciplineand8+ years’ experience in combination product or medical device development of complex technical products

• OR Master's or other advanced degree in engineering or life sciences and5+ years experience in combination product or medical device development of complex technical products

• Expert in device design from concept through late-stage development and into commercial production.

• Experience working with research and clinical development teams, solid understanding of related issues and challenges

• Experience in third party management (of manufacturers and vendors) is preferred

• Expertise around regulatory requirements for parenteral combination products is preferred (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366)

• Strong knowledge of the US/EU external device-mediated drug delivery technology innovation eco-system

• Solid experience in technology development through external partnership with third parties

• Experience with autoinjectors a plus

Soft skills:

• Strong leadership, communication, and presentation skills

• Capable of capturing unmet needs and translating them into product requirements

• International business experience leading multicultural and / or multinational team(s)

• “Play to Win” mindset

• Extensive experience with successfully influencing and rapid decision making in matrix and / or governance driven environments

• Attention to details with meticulous planning

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.