Director, Human Factors & Usability Engineering

Sanofi; Northern (KY); Hybrid; USD 179,000 - 258,000; Full time

Job summary

Sanofi is seeking a Director of Human Factors & Usability Engineering in the US to lead complex HF/UE programs across the GDPU portfolio. The role covers the full lifecycle from user needs to regulatory submission strategy, with engagement across FDA, EMA, and Notified Bodies.

Requires 10+ years in HF/UE for combination products, strong leadership, and cross-functional collaboration without formal authority.

Qualifications

• 10+ years of HF/UE experience in combination product development
• Experience delivering regulatory HF/UE solutions
• Ability to lead complex, high-stakes HF/UE programs with minimal oversight
• Experience with health authority interactions (FDA/EMA/Notified Bodies) and regulatory submissions

Responsibilities

• Lead complex, high-stakes HF/UE programs across the GDPU portfolio.
• Drive HF/UE lifecycle activities from user needs to DHF/UEF documentation and regulatory strategy.
• Shape HF/UE vision and roadmap aligned with product development priorities.
• Mentor HF/UE professionals and contribute to organizational capability and standards

Skills

Leadership

Regulatory knowledge

Stakeholder management

Communication

HF/UE lifecycle

Education

Bachelor's or Master's in HF/psych/biomedical/industrial design

Job description

Sanofi is seeking a Director of Human Factors & Usability Engineering in the US to lead complex HF/UE programs across the GDPU portfolio. The role covers the full lifecycle from user needs to regulatory submission strategy, with engagement across FDA, EMA, and Notified Bodies.

Requires 10+ years in HF/UE for combination products, strong leadership, and cross-functional collaboration without formal authority.