HFUE Associate Director

Job Title : HFUE Associate Director Location : Morristown, NJ About the Job As Human Factors & Usability Engineering Associate Director, you will lead HF/UE strategy and execution across multiple programs and business units at Sanofi. You will shape team processes, mentor HF/UE professionals, and contribute to regulatory strategy and external engagement under the direction of the Director and Global Head of HF/UE. The role requires leading 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 methodologies and tools, and influence organizational direction while developing the next generation of HF/UE talent. Main Responsibilities Lead HF/UE strategy and execution across multiple programs and business units. Drive user-centered design processes across the product portfolio, ensuring decisions are grounded in research and risk-based thinking. Shape and continuously improve HF/UE processes, methodologies, tools, and templates to align with 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, task analysis, known use problems analysis, and 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 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 the assigned portfolio, including delivers, 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 degree in Engineering, Human Factors Psychology, Industrial Design, Life Sciences or related fields. 10+ years of progressive experience in medical device human factors engineering or usability engineering. Mastery of 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 influence across cross-functional teams. Track record of defining and implementing HF/UE processes, methodologies, and best practices. Deep expertise in generative research, formative evaluation, summative validation, and use-related risk analysis. Excellent written and spoken communication skills in English, with the ability to present complex concepts to diverse audiences. Willingness to travel to study sites up to 20%. Preferred Qualifications Master's degree in a related field. Experience in design disciplines (user-centric, industrial, IFU, graphic), engineering fields, regulatory and risk management, requirements generation, clinical practice, or post‑market activities. Experience leading FDA, EMA, or Notified Body submissions and regulatory interactions. Experience with portfolio-level HF/UE strategy and cross‑functional governance. Knowledge of IFU and instructional design for combination products or medical devices. Benefits Competitive salary range of $148,500.00 – $214,500.00, commensurate with experience. Comprehensive rewards package that includes health and well‑being benefits, prevention and wellness programs. Paid parental leave of at least 14 weeks, gender‑neutral. Opportunities for career growth with promotions or lateral moves at home or internationally. Engagement in projects that shape the future of medicine and vaccine delivery. Use of digital, data, and AI‑driven innovation in a fast‑paced environment. Access to benefits information through company channels. Equal Opportunity Employment 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, sexual orientation, disability, veteran or 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. #J-18808-Ljbffr Mass Digital Health