HFUE Associate Director

About the role

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.

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 Lifecycle Management (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

• 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%).

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 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%).

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.