Director, Human Factors and Usability Engineer

Director, Human Factors and 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
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?
Our Purpose and Team:
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 Director, Human Factors and Usability Engineer will apply deep knowledge and industry experience to advance the practices, capabilities, and competency of the HF/UE team and cross-functionally. This role will partner with the Global Device & Packaging Senior Director of Human Factors / Usability Engineering to build best in class team, refine processes, procedures, methods, and tools. You will be responsible for all aspects of HF/UE strategy and activities from early engagement through LCM as an individual contributor while mentoring and providing strategic support to others within the team. HF/UE responsibilities include the development of User Needs & User Requirements 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.
Main Responsibilities:

• 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 medical devices, drug delivery combination products, medicinal product, small molecules, SaMD, and IVD.
• 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.
• Collaborates closely with multidisciplinary teams including clinical, regulatory, device, quality/ risk management, and other global functions to harmonize expectations and ways of working.

Required Skills:

• Bachelor's degree with 10+ years of relevant experience or a master's degree with 6+ years of relevant experience
• 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.
• Must have deep FDA experience and demonstrated the application of your expertise and knowledge through all aspects of the development process in accordance with relevant FDA HF Guidance(s), IEC 62366, ISO 14971, ISO 13485, QBD, EN 60601, and HE75 and our internal QMS.
• Strong foundation in defining, translating, and validating User Needs.
• Possesses deep expertise in iterative UI-Design Process, a solid foundation in User-Centered Design Principles, the Development Process, spanning feasibility through LCM including application of risk management, generating deliverables for Usability Engineering File, Design Controls, and Regulatory submissions.
• 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.
• Experience with digital health devices (SaMD), IVDs, companion diagnostics is highly desirable.

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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.
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