**Job title** : Senior Design Engineer **Location:** Cambridge, MA, Bridgewater, NJ **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. 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 disciplineand **8+** 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 and **5+** 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. \#GD-SA ​ \#LI-SA \#LI-Onsite \#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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _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. 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 (https://youtu.be/96EwNjb1TLo) 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 (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)