Human Factors and Usability Engineering Director

Job Title : Human Factors & Usability Engineering Director Location: Morristown, NJ or Cambridge, MA About the Job Drug 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 Responsibilities Lead 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 LCM Drive 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 strategy Shape and advance HF/UE vision, strategy, and roadmap in partnership with the Senior Director, ensuring alignment with product development priorities and evolving global regulatory expectations Lead and support external health authority engagement and regulatory interactions (FDA, EMA, Notified Bodies, NMPA) across combination products, medical devices, and SaMD Establish, harmonize, and continuously improve HF/UE processes, methodologies, tools, and templates to ensure scalability, consistency, and alignment with current FDA, EMA, and international standards Influence cross-functional teams (clinical, regulatory, device, quality/risk) to embed user-centered design principles throughout product development without formal authority Mentor and develop HF/UE professionals across the team, contributing to organizational capability, scientific rigor, and a culture of continuous improvement Advance HF/UE as a strategic differentiator through thought leadership, contribution to industry standards (AAMI, ISO, IEC), and best practice development at the organizational level About You Basic Qualifications Bachelor's or Master's degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field 10+ 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 pathways Proven 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 oversight Experience 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 guidelines Deep 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 strategy Proven ability to establish user needs, translate them into user requirements, and drive user-centric User Interface (UI) design decisions Experience contributing to HF/UE regulatory submissions and health authority interactions across multiple combination product types and regulatory pathways Leadership & Organizational Impact: Demonstrated ability to influence cross-functional teams and drive HF/UE integration across complex, matrixed organizations without formal authority Track record of mentoring and developing HF/UE professionals and contributing to organizational capability Excellent communication and stakeholder management skills Proven ability to contribute to and advance HF/UE processes, standards, and best practices at a team or organizational level Preferred Qualifications: Proven expertise in combination produ