Director, Human Factors & Usability Engineering

Industrial Design; Cambridge (MA); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

High-quality healthcare

Parental leave (14+ weeks)

Global opportunities

Job summary

Sanofi Inc. seeks a Director of Human Factors & Usability Engineering to lead HF/UE programs across the Global Device and Packaging Unit portfolio. You will guide user-centered strategies from early needs through Lifecycle Management, and oversee regulatory interactions with FDA, EMA, and other bodies.

This senior role influences decisions across development programs and company-wide HF/UE standards. You will mentor a team of HF/UE professionals, align HF/UE plans with product priorities, and

Qualifications

• Bachelor's or Master's degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field.
• 10+ years of Progressive experience in Human Factors and Usability Engineering with deep experience in combination product development across multiple therapeutic areas and regulatory pathways.
• Proven track record of delivering regulatory-compliant HF/UE solutions for combination products across lifecycle stages.

Responsibilities

• Lead complex, high-stakes HF/UE programs across the GDPU portfolio with minimal oversight.
• Drive the full HF/UE lifecycle from user needs to LCM, URRA, and DHF/UEF documentation.
• Shape HF/UE vision, strategy, and roadmap in partnership with senior leadership.
• Lead external health authority engagements (FDA, EMA, Notified Bodies, NMPA) across combination products.
• Establish and continuously improve HF/UE processes, tools, and templates.
• Mentor HF/UE professionals and contribute to organizational capability.
• Advance HF/UE as a strategic differentiator through industry standards and best practices.

Skills

HF/UE expertise

Regulatory engagement

Cross-functional influence

Stakeholder management

Education

Bachelor's or Master's in HF Eng, Psychology, Biomed Eng, Industrial Design, or related

Tools

UEF/DHF documentation

URRA methodology

HF/UE regulations

Job description

Sanofi Inc. seeks a Director of Human Factors & Usability Engineering to lead HF/UE programs across the Global Device and Packaging Unit portfolio. You will guide user-centered strategies from early needs through Lifecycle Management, and oversee regulatory interactions with FDA, EMA, and other bodies.

This senior role influences decisions across development programs and company-wide HF/UE standards. You will mentor a team of HF/UE professionals, align HF/UE plans with product priorities, and