Director, Human Factors & Usability Engineering

BioSpace; Morristown (NJ); On-site; USD 180,000 - 230,000; Full time

Job summary

Sanofi Inc. is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ (with Cambridge, MA option).

You will lead complex HF/UE programs across the Global Device and Packaging Unit, shaping strategy and aligning with regulatory expectations to deliver user-centered medical device and combination product solutions. You will drive the HF/UE lifecycle from needs through LCM, engage with health authorities worldwide, and mentor teams while advancing industry standards and best

Qualifications

• Bachelor’s or Master’s degree in Human Factors Engineering, Psychology, Biomedical Engineering, Industrial Design, or related field.
• 10+ years of HF/UE experience in combination product development across regulatory pathways.
• 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).

Responsibilities

• Lead high-stakes HF/UE programs across the GDPU portfolio from early-stage user needs to Lifecycle Management.
• Oversee complete HF/UE lifecycle: needs, requirements, URRA, KUPs, study design, DHF/UEF, regulatory strategy.
• Shape HF/UE vision and roadmap aligned with product priorities and regulatory expectations.
• Engage with health authorities and regulatory bodies across device and SaMD products.
• Harmonize HF/UE processes, tools, and templates to ensure scalability and standard compliance.
• Influence cross-functional teams to embed user-centered design without formal authority.
• Mentor HF/UE professionals and build organizational capability.
• Advance HF/UE practice to differentiate products and contribute to industry standards.

Skills

HF/UE leadership

Regulatory interactions

Stakeholder management

Cross-functional influence

Mentoring HF/UE

Education

Bachelor’s or Master’s in Human Factors/related field

Job description

Sanofi Inc. is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ (with Cambridge, MA option).

You will lead complex HF/UE programs across the Global Device and Packaging Unit, shaping strategy and aligning with regulatory expectations to deliver user-centered medical device and combination product solutions. You will drive the HF/UE lifecycle from needs through LCM, engage with health authorities worldwide, and mentor teams while advancing industry standards and best