Global Director, Human Factors & Usability Engineering

Mass Digital Health; Cambridge (MA); On-site; USD 179,000 - 258,000; Full time

Benefits offered by this job

14 weeks parental leave

Comprehensive healthcare

Global opportunities

Job summary

Sanofi Inc. is seeking a Director of Human Factors & Usability Engineering to lead complex HF/UE programs across the Global Device and Packaging Unit (GDPU).

The role partners with the Head of HF/UE to drive strategy, ensure regulatory alignment, and shepherd user-centered design from early concept through Lifecycle Management. The incumbent will mentor HF/UE professionals, influence cross-functional teams without formal authority, and advance HF/UE as a differentiator by contributing to

Qualifications

• Bachelor's or Master's degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field.
• 10+ years of progressive HF/UE experience across device and regulatory paths.
• Proven track record delivering regulatory-compliant HF/UE solutions for combination products.
• Experience leading complex 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 with minimal oversight.
• Drive the full HF/UE lifecycle hands-on: URRA, study design, UEF/DHF docs, regulatory strategy.
• Shape and advance HF/UE vision, strategy, and roadmap with product development priorities.
• Lead and support external health authority engagement and regulatory interactions.
• Establish, harmonize, and improve HF/UE processes, tools, and templates.
• Influence cross-functional teams to embed user-centered design principles.
• Mentor and develop HF/UE professionals and organizational capability.
• Advance HF/UE as a strategic differentiator through standards contributions.

Skills

HF/UE leadership

Regulatory interactions

User-centered design

Cross-functional influence

Stakeholder management

Education

Bachelor's or Master's in HF Engineering/PSY/BME/Industrial Design

Job description

Sanofi Inc. is seeking a Director of Human Factors & Usability Engineering to lead complex HF/UE programs across the Global Device and Packaging Unit (GDPU).

The role partners with the Head of HF/UE to drive strategy, ensure regulatory alignment, and shepherd user-centered design from early concept through Lifecycle Management. The incumbent will mentor HF/UE professionals, influence cross-functional teams without formal authority, and advance HF/UE as a differentiator by contributing to