Strategic Leader, Human Factors & Usability Engineering

Sanofi Group; Morristown (NJ); On-site; USD 179,000 - 258,000; Full time

Job summary

Sanofi is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ, to lead global HF/UE programs spanning early user needs to Lifecycle Management across parenteral devices. This senior role partners with the Head of HF/UE to shape strategy, ensure regulatory alignment, and drive user-centered decision making.

The role requires deep expertise in HF/UE across combination products, strong regulatory interactions, and the ability to influence cross-functional teams without

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 combination products and 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).
• Mastery of FDA HF Guidance, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, HE75, EMA guidelines.
• Deep lifecycle HF/UE expertise across user needs to DHF/UEF documentation.
• Translate user needs into UI design decisions.
• Contribute to HF/UE regulatory submissions and health authority interactions.
• Influence cross-functional teams without formal authority.
• Mentor HF/UE professionals and build organizational capability.
• Excellent communication and stakeholder management.
• Advance HF/UE processes and standards at team/organization level.

Responsibilities

• Lead complex, high-stakes HF/UE programs across the GDPU portfolio with minimal oversight, owning deliverables across the full product lifecycle from early-stage user needs through LCM
• Drive the full HF/UE lifecycle hands-on: user needs, use requirements, context of use, Known Use Problems (KUPs), Use-Related Risk Analysis (URRA), study design and execution, UEF/DHF documentation, and regulatory submission strategy
• 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) across combination products, medical devices, and SaMD
• Establish, harmonize, and continuously improve HF/UE processes, methodologies, tools, and templates for scalability and standards alignment
• Influence cross-functional teams (clinical, regulatory, device, quality/risk) to embed user-centered design principles
• Mentor HF/UE professionals across the team and contribute to organizational capability
• Advance HF/UE as a strategic differentiator through thought leadership and industry standards participation

Skills

HF/UE leadership

Regulatory engagement

Stakeholder management

Mentoring

Strategy development

Cross-functional collaboration

Education

Bachelor's or Master's in HF/Eng

Job description

Sanofi is seeking a Director of Human Factors & Usability Engineering in Morristown, NJ, to lead global HF/UE programs spanning early user needs to Lifecycle Management across parenteral devices. This senior role partners with the Head of HF/UE to shape strategy, ensure regulatory alignment, and drive user-centered decision making.

The role requires deep expertise in HF/UE across combination products, strong regulatory interactions, and the ability to influence cross-functional teams without