Human Factors and Usability Engineering Director

Job Title: Human Factors & Usability Engineering DirectorLocation: Morristown, NJ or Cambridge, MAAbout the JobDrug Product Development & Delivery is a global business unit in Manufacturing & Supply (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 early stage, development. and Lifecycle Management (LCM) projects of drug delivery devices for monoclonal antibodies (mAbs), vaccines, peptides, genomics, and more.The Director, Human Factors & Usability Engineering is a senior individual contributor role responsible for leading complex Human Factors and Usability Engineering (HF/UE) programs across the Global Device and Packaging Unit (GDPU) portfolio. Working closely with the Head of HF/UE, this role brings deep technical expertise and organizational influence to drive product excellence, contribute to HF/UE strategy and direction, and support health authority engagements. The Director owns significant responsibilities across the full product lifecycle from early-stage user needs through Lifecycle Management (LCM) and is highly relied upon to lead the most complex, high-stakes programs while advancing HF/UE as a strategic differentiator across the organization, strengthening how user-centered thinking shapes decisions from early concept through launch. 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.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 lives.Main ResponsibilitiesLead complex, high-stakes HF/UE programs across the GDPU portfolio with minimal oversight, owning deliverables across the full product lifecycle from early-stage user needs through LCMDrive the full HF/UE lifecycle hands-on: user needs, use requirements, context of use, Known Use Problems (KUPs), Use-Related Risk Analysis (URRA), generative/formative/summative study design and execution, UEF/DHF documentation, and regulatory submission strategyShape and advance HF/UE vision, strategy, and roadmap in partnership with the Senior Director, ensuring alignment with product development priorities and evolving global regulatory expectationsLead and support external health authority engagement and regulatory interactions (FDA, EMA, Notified Bodies, NMPA) across combination products, medical devices, and SaMDEstablish, harmonize, and continuously improve HF/UE processes, methodologies, tools, and templates to ensure scalability, consistency, and alignment with current FDA, EMA, and international standardsInfluence cross-functional teams (clinical, regulatory, device, quality/risk) to embed user-centered design principles throughout product development without formal authorityMentor and develop HF/UE professionals across the team, contributing to organizational capability, scientific rigor, and a culture of continuous improvementAdvance HF/UE as a strategic differentiator through thought leadership, contribution to industry standards (AAMI, ISO, IEC), and best practice development at the organizational levelAbout You Basic QualificationsBachelor's or Master's degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field10+ years of progressive experience in Human Factors and Usability Engineering with deep, demonstrated experience in combination product development including drug-device combination products across multiple therapeutic areas and regulatory pathwaysProven track record of delivering regulatory-compliant HF/UE solutions for combination products, spanning feasibility through Lifecycle Management (LCM)Demonstrated experience leading complex, high-stakes HF/UE programs with minimal oversightExperience supporting or leading health authority interactions (Food and Drug Administration (FDA), European Medicines Agency (EMA), Notified Bodies, National Medical Products Administration (NMPA)Technical Expertise:Mastery of FDA HF Guidance documents, International Electrotechnical Commission (IEC) 62366-1:2015+A1:2020, International Organization for Standardization (ISO) 14971:2019, ISO 13485, HE75, and EMA guidelinesDeep expertise in the full HF/UE lifecycle: user needs, use requirements, context of use, Known Use Problems (KUPs), Use-Related Risk Analysis (URRA), generative/formative/summative study design and execution, Usability Engineering File (UEF)/Design History File (DHF) documentation, and regulatory submission strategyProven ability to establish user needs, translate them into user requirements, and drive user-centric User Interface (UI) design decisionsExperience contributing to HF/UE regulatory submissions and health authority interactions across multiple combination product types and regulatory pathwaysLeadership & Organizational Impact:Demonstrated ability to influence cross-functional teams and drive HF/UE integration across complex, matrixed organizations without formal authorityTrack record of mentoring and developing HF/UE professionals and contributing to organizational capabilityExcellent communication and stakeholder management skillsProven ability to contribute to and advance HF/UE processes, standards, and best practices at a team or organizational levelPreferred Qualifications:Proven expertise in combination product Human Factors and Usability Engineering across multiple therapeutic areas including experience with parenteral delivery systems such as autoinjectors, prefilled syringes, pens, or large volume devicesProfessional experience beyond HF/UE spanning design disciplines (user-centric, industrial, Instructions for Use (IFU), graphic), engineering fields (device, systems, quality), regulatory and risk management, requirements generation, clinical practice, or post-market activities considered a meaningful differentiatorExperience with emerging technologies including Software as a Medical Device (SaMD), digital health, and AI/ML in medical devicesTrack record of advancing HF/UE practices and methodologies within organizationsExperience with portfolio-level HF/UE strategy and cross-functional governanceBroad therapeutic area experience spanning monoclonal antibodies (mAbs), vaccines, peptides, genomics, and/or small moleculesWhy 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.Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scaleTransform lives worldwide by delivering life-changing treatments anywhere, anytime.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.#GD-SA#LI-SA#vhd#LI-HybridPursue progress, discover extraordinaryBetter 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.Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 View phone number on click.appcast.io) or click hereUS and Puerto Rico Residents OnlySanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.North America Applicants OnlyThe salary range for this position is:$178,500.00 - $257,833.33All 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.SummaryLocation: Morristown, NJ; Cambridge, MAType: Full time