HFUE Associate Director

Sanofi•Morristown, NJ

17h•Onsite

About The Position

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.

Requirements

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 any 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%)

Nice To Haves

Masters degreein 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

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