Strategic Director, Human Factors & Usability Engineering

Sanofi; Morristown (NJ); On-site; USD 210,000 - 270,000; Full time

Job summary

Sanofi is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ (or Cambridge, MA) to lead complex HF/UE programs across the Global Device and Packaging Unit. You will drive user-centered design across the full lifecycle from early needs through Lifecycle Management, partnering with the Head of HF/UE and integrating regulatory expectations.

You will influence cross-functional teams, shape HF/UE strategy, and mentor professionals to advance HF/UE as a strategic

Qualifications

• 10+ years of progressive experience in Human Factors and Usability Engineering with deep, demonstrated experience in combination product development and regulatory pathways
• Proven track record delivering regulatory-compliant HF/UE solutions for combination products from feasibility through Lifecycle Management (LCM)
• Demonstrated experience leading complex, high-stakes HF/UE programs with minimal oversight
• Experience supporting or leading health authority interactions (FDA, EMA, Notified Bodies, NMPA)

Responsibilities

• Lead complex, high-stakes HF/UE programs across the GDPU portfolio from early-stage needs through LCM
• Drive the HF/UE lifecycle: user needs, use requirements, context of use, URRA, study design and execution, DHF/UEF documentation
• Shape HF/UE vision, strategy, and roadmap in partnership with Senior Director
• Lead external regulatory engagement across FDA, EMA, Notified Bodies, NMPA
• Establish and improve HF/UE processes, tools, and templates for scalability and standards
• Influence cross-functional teams to embed user-centered design throughout development
• Mentor HF/UE professionals and contribute to organizational capability
• Advance HF/UE as a differentiator through leadership and industry standards

Skills

HF/UE expertise

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's or Master's degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field

Tools

FDA HF Guidance documents

IEC 62366-1

ISO 14971/13485

Job description

Sanofi is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ (or Cambridge, MA) to lead complex HF/UE programs across the Global Device and Packaging Unit. You will drive user-centered design across the full lifecycle from early needs through Lifecycle Management, partnering with the Head of HF/UE and integrating regulatory expectations.

You will influence cross-functional teams, shape HF/UE strategy, and mentor professionals to advance HF/UE as a strategic