About the Job

GDPU is a global business Unit in M&S which develops and maintains Sanofi`s parenteral injection system like Insulin Pens, Autoinjectors, Large Volume Devices, infusion systems and Pre-Filled Syringes. The Unit is a project centric organization which is executing development and LCM projects of drug delivery devices for mAbs, vaccines, peptides, genomics etc. and supports device product maintenance post launch.

The Principal Usability Engineer is fully accountable for leading, overseeing and directing GDPU Usability Engineering activities, developing submission documentation and managing to authority (in US, EU, China a.o.) interactions. Further is representing Sanofi as member and been active at international standards organizations like AAMI, ISO, DIN, AFNOR and other, to bring our knowledge and influence standard establishment.

Furthermore, you will build and apply your knowledge and network in industry, at patient associations and with regulators to enhance our product pipeline and related technology innovation strategy. With this you play an important role as window person and key interface to regulators and associations outside Sanofi.

Usability engineering includes the development of User Need and User Requirement as well as the analyses of user Feedback from Studies, Patient associations and open sources like literature, Internet or else.

Main Responsibilities:

• The GDU Principal Usability Engineer is fully responsible for overseeing and directing Usability Engineering activities within the scope of his projects and initiatives.

• Your expertise in human factors engineering, usability, and user-centered design principles will be crucial in ensuring the safe and effective use of medical devices and drug device combination products (such as Autoinjectors, Safety-Syringes, Pens etc.) by healthcare professionals and patients.

• Usability engineering and Human Factors are an area of high expectation by authorities and must therefore be mastered by our products. Your responsibility is to play the key interface to regulators (AAMI, ISO, IEC ao.) as well to authorities (FDA, EMEA, CFDA ao.) to contribute and influence the standard creation and facilitate UE&HF related interaction.

• All Devices and related material like packaging, co-packed component, Instructions for use and related training material must include usability engineering principals to make them best usable and make them comply with the regulations.

About You

• BS with 10+ years or MS with 6+ years of industry experience in human factors/usability or a related field (e.g., biomedical engineering, mechanical engineering, psychology, economics, human-computer interaction, etc.).

• Work experience applying human factors to medical devices or combination products.

• Possesses deep expertise in HF/UE application and solid foundation in user-centered design principles specifically in medical device, drug-delivery, and/or drug-device combination products industry.

• Strong foundation in defining, translating, and validating User Needs.

• Applies deep expertise and knowledge of FDA related HF Guidance(s), ANSI/AAMI/IEC 62366-1, ANSI/AAMI HE75, ISO 14971, the development process, design controls, and regulatory writing.

• Performs well autonomously with minimal oversight executing all aspects of user needs, HF/UE and user-center design activities.

• Must be able to work 2-3 days onsite in a hybrid work model.

• Must be able and willing to travel globally, up to 25% of the time.

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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