Associate-Director, Human Factors and Usability Engineering

Job Title : Associate-Director, Human Factors and Usability Engineering

Location : Morristown, NJ Cambridge, MA

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 Associate Director will be responsible for leading and executing HFUE activities, continuous HFUE process improvements, driving user-centric design, optimizing the product user-interface, ensuring products are safe and effective for use and enhance the overall user experience for products across the strong pipeline. Drive HFUE initiatives in early stage, development, and LCM projects, ensuring strategic and rigorous execution and timely delivery.

This role offers the opportunity to shape the future of medical device usability while working with cutting-edge technology with a global healthcare leader.

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?

Main Responsibilities :

Lead human factors and usability engineering activities throughout product lifecycle

Ensure product safety, effectiveness, and optimal user-interface design

Drive user-centered design processes supporting Sanofi's product pipeline

Collaborate with cross-functional teams to implement HFE best practices

Oversee regulatory compliance and documentation

About You

Basic Qualifications :

Bachelor’s or master’s degree in : Human Factors Engineering, Biomedical Engineering, Biomechanics, Mechanical Engineering, HF Behavioral Sciences or Psychology, Industrial Design or related field

Extensive experience in pharmaceutical or medical device industry

Deep knowledge of combination products and medical device human factors

Strong understanding of FDA Guidance, International Standards, and Global Regulations

Preferred Experience :

Wide range of FDA submission experience

Multidisciplinary perspective in : Device design, User research, Instructional design, Requirements generation, User-centric design across product lifecycle

Technical Expertise :

Strategic implementation of HFUE processes : User needs identification, Use requirements generation, Context of use definition, KUPs and use-related risk controls assessment, URRA execution, Study design and execution, UEF / DHF deliverable management, Regulatory submission documentation

Leadership Competencies :

Strategic thinking and risk-based decision making

Agile leadership mindset

Critical problem-solving abilities

Innovation-driven approach

Excellent communication and collaboration skills

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.