HFUE Associate Director

Job Title HFUE Associate Director Location: Morristown, NJ About the Job As a Human Factors & Usability Engineering, Associate Director, you will lead HF/UE strategy and execution across multiple programs and business units, driving user-centric design and ensuring product safety and effectiveness across Sanofi's product portfolio. This role bridges deep technical expertise with strategic leadership — shaping team processes, mentoring HF/UE professionals, and contributing to regulatory strategy and external engagement under the direction of the Director and Global Head of HF/UE. The HFUE, Associate Director, leads human factors and usability engineering activities across a broad portfolio of drug delivery devices and combination products, from early-stage generative research through summative validation and lifecycle management. You will drive cross-functional HF/UE integration, shape team methodologies and tools, and contribute to regulatory strategy and health authority interactions. This role requires both the ability to lead complex programs independently and the strategic mindset to influence organizational direction and develop the next generation of HF/UE talent. About Sanofi 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. Main Responsibilities Lead HF/UE strategy and execution across multiple programs and business units, ensuring rigorous, fit-for-purpose application of human factors engineering from early engagement through LCM Drive user-centered design processes across the product portfolio, ensuring user needs, use requirements, and UI design decisions are grounded in robust research and risk-based thinking Shape and continuously improve HF/UE processes, methodologies, tools, and templates to advance team capabilities and ensure alignment with current FDA expectations and global standards Lead complex generative, formative, and summative HF/UE studies, including study design, protocol development, execution, data analysis, and reporting Conduct and oversee use-related risk analysis (URRA), task analysis, known use problems analysis, and use-related risk control evaluation across assigned programs Contribute to regulatory strategy and support health authority submissions and interactions Mentor and develop HF/UE team members, providing technical guidance, professional development support, and fostering a culture of excellence and continuous learning Collaborate cross-functionally with design, regulatory, clinical, quality, and marketing teams as a senior HF/UE leader and strategic partner Ensure HF/UE compliance and best practices across assigned portfolio, including UEF/DHF deliverables, design controls, and regulatory documentation Manage and oversee external vendors and consultants supporting HF/UE study execution and program delivery About You Basic Qualifications Bachelor's in Engineering, Human factors Psychology, industrial design, Life sciences or related fields. 10+ years of progressive experience in medical device, product human factors engineering, usability engineering, combination product human factors engineering or related fields. Mastery of all relevant FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines Proven ability to lead and manage complex HF/UE programs across multiple concurrent projects with minimal oversight Strong strategic thinking and demonstrated ability to influence cross-functional teams and drive user-centric outcomes Proven track record of defining and implementing HF/UE processes, methodologies, and best practices within an organization Deep expertise in generative research methods, formative evaluation techniques, summative validation, and use-related risk analysis Excellent communication skills (written and spoken English) with demonstrated ability to present complex HF/UE concepts to diverse audiences Willingness to travel to study sites (up to 20%) Preferred Qualifications: Masters degree in Engineering, Human factors Psychology, industrial design, Life sciences or related fields. Professional experience beyond HF/UE spanning design disciplines (user-centric, industrial, IFU, graphic), engineering fields (device, systems, quality), regulatory and risk management, requirements generation, clinical practice, or post-market activities is highly valued, considered a meaningful differentiator, and strengthens cross-functional influence and HF/UE strategy. Experience leading FDA submissions and regulatory interactions (FDA, EMA, Notified Bodies) Experience with portfolio-level HF/UE strategy and cross-functional governance Knowledge of IFU & instructional design for combination products or medical devices 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. 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 scale Transform 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. 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. #J-18808-Ljbffr Sanofi EU