Strategic Director, Human Factors & Usability Engineering

BioSpace; Morristown (NJ); On-site; USD 190,000 - 230,000; Full time

Benefits offered by this job

14 weeks parental leave

Healthcare and wellbeing benefits

Job summary

Sanofi is seeking a Director of Human Factors & Usability Engineering to lead high-stakes HF/UE programs across the Global Device and Packaging Unit. You will own the full lifecycle from user needs to Lifecycle Management, collaborating with Regulatory, Quality, and Clinical teams to shape strategy and ensure compliant, patient-centered design.

You will drive HF/UE process optimization, mentor professionals, and contribute to industry standards while aligning with FDA/EMA expectations.

Qualifications

• 10+ years in Human Factors and Usability Engineering across drug-device products
• Experience leading HF/UE programs with minimal oversight
• Experience with FDA/EMA health authority interactions and regulatory submissions

Responsibilities

• Lead complex HF/UE programs across the GDPU portfolio
• Drive HF/UE lifecycle design and regulatory submission strategy
• Shape HF/UE vision, strategy, and roadmap
• Mentor HF/UE professionals and build organizational capability
• Engage with health authorities (FDA/EMA/Notified Bodies/NMPA) as needed

Skills

HF/UE leadership

Cross-functional collaboration

Regulatory submissions

Mentoring and coaching

Strategic HF/UE planning

Education

Bachelor's or Master's in HF/UE or related field

Job description

Sanofi is seeking a Director of Human Factors & Usability Engineering to lead high-stakes HF/UE programs across the Global Device and Packaging Unit. You will own the full lifecycle from user needs to Lifecycle Management, collaborating with Regulatory, Quality, and Clinical teams to shape strategy and ensure compliant, patient-centered design.

You will drive HF/UE process optimization, mentor professionals, and contribute to industry standards while aligning with FDA/EMA expectations.