Human Factors and Usability Engineer

Sanofi • Morristown, MA

3d

About The Position

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. Our Purpose & Team: GDPU is a global business unit in M&S which develops and maintains Sanofi's parenteral injection systems including Insulin Pens, Autoinjectors, Large Volume Devices, infusion systems, and Pre-Filled Syringes. The unit is a project-centric organization executing development and lifecycle management (LCM) projects of drug delivery devices for mAbs, vaccines, peptides, genomics, and more, and supports device product maintenance post-launch. The Human Factors & Usability Engineer will support GDPU HF/UE activities for medical devices, combination products, and medicinal products as applicable across our deep pipeline from early engagement through lifecycle management. This role operates with meaningful autonomy while benefiting from mentorship and oversight that supports professional growth and development. Responsibilities span the full HF/UE lifecycle from early-stage generative research and user characterization through formative evaluation, iterative design support, and summative validation with contributions to user needs analysis, user requirements development, task analysis, use-related risk analysis, user interface (UI) design support, and usability study execution. Our team supports our mission to make the impossible possible by delivering 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, and ensuring a user-centric approach to informing the user-interface design of our products. Ultimately, we are committed to ensuring our products meet the needs of users, reducing use-related issues, optimizing user interface design to support safe and effective use, improving overall usability, and enhancing the patient experience. 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.

Requirements

• Education: Bachelor's degree in human factors, psychology, biomedical engineering, or related field (e.g., cognitive science, engineering sciences, human-computer interaction)
• Experience: 2.5 to 5 years applying human factors engineering to medical devices or combination products
• Health Authority & Standards knowledge: all relevant FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, EMA guidelines
• Experience designing and executing generative, formative, and summative usability studies
• Strong cross-functional collaboration and communication skills (written and spoken English)
• Ability to work autonomously, seek guidance when needed, and thrive within a matrix organization with mentorship support
• Willingness to travel to study sites (up to 20%)
• High self-motivation and passion for human factors and patient-centered design

Nice To Haves

• Master's degree in human factors or related field
• Proficiency in user-centric design principles and tailored application of HF principles through systematic, risk-based, fit-for-purpose, tailored processes aligned with latest FDA expectations and relevant FDA Guidance documents
• Experience moderating usability tests and managing external vendors
• Knowledge of instructional design and package/labeling design for medical devices
• Experience with health authority submissions and regulatory interactions (FDA, EMA, Notified Bodies)
• Understanding of drug-device development lifecycle, change control, and LCM processes
• Ability to analyze qualitative and quantitative data, including basic statistics
• Familiarity with design and prototyping methods and tools

Responsibilities

• Conduct early-stage generative research (ethnographic methods, contextual inquiry, participatory design) to discover user needs, contexts of use, and unmet needs
• Execute user characterization studies to systematically explore the capabilities, limitations, and variability of intended user populations, including those with physical, sensory, or cognitive impairments, to ensure findings inform appropriate user requirements, UI specifications, and design decisions for safe and effective use
• Perform functional task analysis, use-related hazard analysis, and known use problems analysis to inform use-related risk analysis and identify, assess, and prioritize use-related risk controls and mitigation strategies
• Apply good study design to enable iterative UI design leveraging a range of research and testing methods to lead or conduct formative research including heuristic evaluations, cognitive walkthroughs, iterative labeling testing, and sprint studies
• Conduct use error analysis and root cause analysis to distinguish design-induced errors and inform UI design improvements
• Translate study results and technical constraints into user needs, design recommendations, and UI specifications
• Develop study protocols and execute summative validation studies to demonstrate safe and effective use
• Apply instructional and visual design principles to develop Instructions for Use (IFU), labeling, and patient support program content
• Support regulatory submissions and health authority interactions (FDA, EMA, Notified Bodies, NMPA) under direction of the Global Head of HFUE
• Collaborate with cross-functional teams (design, regulatory, clinical, quality, marketing) as the HF/UE representative
• Support vendor and consultant activities for usability study execution
• Contribute to HF/UE process improvements, tools, and knowledge sharing initiatives

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level