Senior, Human Factors and Usability Engineer

Job Title: Senior, Human Factors and Usability Engineer

Location: Cambridge, MA, Morristown, NJ

About the Job

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

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

The Senior Human Factors & Usability Engineer will execute and support GDPU HF/UE activities from early engagement through LCM. Responsibilities include contributing to submission strategies and planning, conducting user needs analysis, supporting user requirements development, performing task analysis, conducting use-related risk analysis, supporting user interface (UI) design, and executing formative and summative validation studies. You will contribute to expanding HF/UE knowledge and may participate in international standards organizations like AAMI, ISO, DIN, AFNOR to support knowledge sharing and standard development.

You will build and apply your knowledge and network in industry, at patient associations and with regulators to support our product pipeline and related technology innovation strategy. You will serve as a key contributor to regulatory and association interactions outside Sanofi.

Usability engineering includes supporting the development of User Needs and User Requirements as well as analyzing user feedback from studies, patient associations and open sources like literature, internet and other sources.

Our team will support our mission to make the impossible possible by better informing the user-interface design of our products, ensuring they are safe and effective for use, improving overall usability, reducing use-related errors, while providing best-in-class and first-in-class products.

Working together to define user needs and establish user requirements that meet the unmet needs of patients.

About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main Responsibilities:

• The Senior Human Factors & Usability Engineer will provide subject matter expertise to support strategy, planning, and execution of fit-for-purpose HF/UE activities for programs across the Sanofi portfolio from early engagement through LCM.
• Applying generative, formative and summative research methods under guidance and independently for routine studies.
• Supporting HFE strategies and executing HF activities on drug delivery device technology development and/or drug-device combination product program teams from early-stage development to new product introduction and support for on-market products.
• In this role you will contribute to advancing HF/UE processes, procedures, tools and methods with the goal of maximizing the value of HF involvement.

Additional Responsibilities:

• Support usability engineering and Human Factors compliance with authority expectations and contribute to regulatory interactions (AAMI, ISO, IEC) as well as authorities (FDA, EMEA, CFDA) under the direction of the Head of HF/UE.
• Ensure all devices and related materials like packaging, co-packed components, Instructions for Use and related training materials incorporate usability engineering principles for optimal usability and regulatory compliance.
• Support program strategies and contribute to identifying potential risks and developing actionable strategies aligned with industry best practices and health authority expectations.
• Work with internal and external resources to support agility and ensure fit-for-purpose capabilities, contributing to expanding collective HF expertise.

*Your expertise in human factors engineering, usability, and user-centered design principles will contribute to 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.

About You

Required Skills:

• Bachelor's or master's degree in Human Factors Engineering, Biomedical Engineering, Biomechanics, Mechanical Engineering, HF Behavioral Sciences, Psychology, Industrial Design, or related field.
• Extensive experience in the pharmaceutical or medical device industry.
• Strong knowledge and practical application of human factors engineering, design controls, and risk management standards and guidances (e.g., IEC 62366, FDA HF Guidance, ISO 14971) across end-to-end combination product development.
• Demonstrated analytical thinking, problem-solving, and research design skills; ability to analyze data with proficiency in basic statistics.
• Experience planning and executing ethnographic, formative, and summative usability studies, with or without external vendors.
• Ability to translate study insights and technical constraints into clear user needs and actionable design recommendations.
• Strong cross-functional collaboration and interpersonal skills.
• Ability to work independently with appropriate guidance and oversight.

Preferred:

• Experience in package design and development of safety-critical information to support product use and user interface design.
• Experience creating instructional materials and patient support programs for new product introductions and on-market support.
• Working knowledge of periodic risk reviews and change control processes for on-market drug-device combination products.
• Experience with health authority submissions and interactions (e.g., FDA, EMA, Notified Bodies).
• Understanding of drug-device development and the integration of HF/UE with market research, risk management, design controls, and lifecycle management processes.
• Expertise in human factors engineering, usability engineering, and user-centered design principles for medical devices and combination products.
• Ability to adapt to a rapidly changing environment.

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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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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.

North America Applicants Only

The salary range for this position is:
$122,250.00 - $176,583.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.