Director of Human Factors & Usability Engineering

Sanofi; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sanofi is seeking a Human Factors & Usability Engineering Director to lead complex HF/UE programs across the Global Device and Packaging Unit. You will own the full lifecycle from user needs to Lifecycle Management, shaping HF/UE strategy, and guiding regulatory submissions with FDA, EMA, and Notified Bodies.

In this senior role, you will mentor HF/UE teams, influence cross‑functional partners without formal authority, and advance HF/UE as a strategic differentiator across the organization while

Qualifications

• 10+ years of progressive experience in HF/UE across drug-device combination products.
• Proven track record delivering regulatory‑compliant HF/UE solutions.
• Experience supporting health authority interactions (FDA, EMA, Notified Bodies, NMPA).
• Ability to lead complex, high‑stakes HF/UE programs with minimal oversight.
• Deep knowledge of FDA HF Guidance and IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485.

Responsibilities

• Lead complex, high‑stakes HF/UE programs across the GDPU portfolio with minimal oversight, owning deliverables across the full product lifecycle.
• Shape and advance HF/UE vision, strategy, and roadmap in partnership with the Senior Director, ensuring alignment with development priorities and regulatory expectations.
• Lead and support external health authority engagement and regulatory interactions (FDA, EMA, Notified Bodies, NMPA).
• Establish, harmonize, and continuously improve HF/UE processes, methodologies, tools, and templates to ensure scalability and consistency.
• Mentor and develop HF/UE professionals across the team and contribute to organizational capability.
• Influence cross‑functional teams to embed user‑centered design throughout product development without formal authority.

Skills

Human Factors Engineering

Usability Engineering

Cross-functional leadership

Regulatory submissions

Mentoring

Education

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

Job description

Sanofi is seeking a Human Factors & Usability Engineering Director to lead complex HF/UE programs across the Global Device and Packaging Unit. You will own the full lifecycle from user needs to Lifecycle Management, shaping HF/UE strategy, and guiding regulatory submissions with FDA, EMA, and Notified Bodies.

In this senior role, you will mentor HF/UE teams, influence cross‑functional partners without formal authority, and advance HF/UE as a strategic differentiator across the organization while