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Principal Human Factors/ Usability Engineer

Location: Cambridge, MA or Bridgewater, NJ

Hybrid work model- must be able to commit to 2-3 days onsite/week.

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 will apply deep knowledge and industry experience to advance the practices, capabilities, and competency of the HF/UE team and cross-functionally. You will be responsible for all aspects of HF/UE strategy and activities from early engagement through LCM. HF/UE responsibilities include the development of User Need and User Requirement and ensuring user-centric design principles are applied. Human Factors and Usability Engineering is fundamental to ensuring our product safety, usability, and effectiveness and continues to be a rapidly evolving priority of health authorities.

• Provides HF/UE subject matter expertise to cross-functional global teams, interacting with experts in industry, clinical operations, marketing, medical, engineering, quality, risk management, packaging, labeling, and regulatory affairs.

• Supports Innovation playing a key role in establishing user needs, translation of user needs into requirements and user driven specifications, informing product UI-Design, defining & developing adequate prototypes for evaluation, analyzing research/ study results and other sources of user data to inform UI-design iterations, and evaluating effectiveness and impact of use-related risk controls.

• Defines fit-for-purpose HF submission strategies and project plans, develop user needs and user requirements, perform task analysis, inform user interface (UI) design, define research/ evaluation methods, analyze data, perform use-related risk analysis, perform all aspects of formative and summative validation studies, develop submission content, engage with health authorities, support HF inputs of label negotiations, launch, and continuous improvement efforts.

• Provides strategic guidance to our external partners, vendors, and clients on the application of HF/UE best practices across Sanofi’s portfolio of products including devices, drug delivery combination products, medicinal product, small molecules, SaMD, and IVD.

• Collaborates closely with clinical, regulatory, device, quality/ risk management, and other functions to harmonize expectations and ways of working together that satisfy Design History File/Design Control requirements including risk management, verification and validation, and HF specific requirements such as development of user needs, user requirements, context of use, UI-Design evaluation, hazard analysis, user-related risk analysis, and HF validation.

About you:

• Bachelor’s degree with 10+ years of relevant experience or a master’s degree with 6+ years of relevant experience

• 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, demonstrating critical thinking and complex problem solving.

• 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.

• Deep experience engaging with FDA, EMA, notified bodies spanning medical device, drug-device combination products, medicinal product, SaMD, and IVD with strong preference for FDA experience.

• Ability to lead and execute complex programs, work on, and communicate well within a globally based team, influence multi-functional partners, adapt to a rapidly changing environment, and effectively lead external consultants.

• Ability to lead, define, moderator generative research like observational, human capabilities and limitations, ethnographic, innovation research design to gather, synthesize and translate into meaningful data to inform all aspects of UI-Design resulting in improved usability.

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.

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