Senior Director, Human Factors & Usability Engineering

Sanofi; Northern (KY); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Healthcare benefits

Parental leave

Career growth

Global opportunities

Job summary

Sanofi is seeking a Director of Human Factors & Usability Engineering to lead complex HF/UE programs across the Global Device and Packaging Unit. You will drive user-centered design, URRA, and regulatory strategy from early concept through Lifecycle Management, partnering with regulatory bodies and senior leadership.

The role emphasizes shaping HF/UE vision, aligning with development priorities, and mentoring a team to strengthen organizational capability while driving strategic differentiators

Qualifications

• Bachelor's or Master's in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field.
• 10+ years of Progressive experience in HF and Usability Engineering across drug-device combos.
• Proven track record delivering regulatory-compliant HF/UE solutions.
• Experience leading complex HF/UE programs with minimal oversight.
• Experience with health authority interactions (FDA, EMA, NMPA, Notified Bodies) as applicable.

Responsibilities

• Lead complex HF/UE programs across the GDPU portfolio with minimal oversight.
• Oversee end-to-end HF/UE lifecycle from user needs to LCM and regulatory submission strategy.
• Shape HF/UE vision and roadmaps in line with product priorities and regulatory expectations.
• Engage with health authorities (FDA, EMA, Notified Bodies, NMPA) across products.
• Develop and harmonize HF/UE processes, tools, and templates for scalability and compliance.
• Influence cross-functional teams to embed user-centered design principles.
• Mentor HF/UE professionals and strengthen organizational capability.
• Advance HF/UE as a strategic differentiator through standards and thought leadership.

Skills

HF/UE leadership

Regulatory submissions

Cross-functional collaboration

Strategic thinking

Education

Bachelor's or Master's in HF/UX/Related

Tools

FDA HF Guidance

IEC 62366-1

ISO 14971/ISO 13485

Job description

Sanofi is seeking a Director of Human Factors & Usability Engineering to lead complex HF/UE programs across the Global Device and Packaging Unit. You will drive user-centered design, URRA, and regulatory strategy from early concept through Lifecycle Management, partnering with regulatory bodies and senior leadership.

The role emphasizes shaping HF/UE vision, aligning with development priorities, and mentoring a team to strengthen organizational capability while driving strategic differentiators