Hfue Associate Director

Sanofi Genzyme

Morristown, NJ, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
10+ years medical device human factors experience
Mastery of fda hf guidance and iec 62366-1
Lead generative formative summative hf studies
This role leads Human Factors & Usability Engineering strategy across multiple programs to ensure product safety and effectiveness for Sanofi's drug delivery devices

Job Summary

  • This role leads Human Factors & Usability Engineering strategy across multiple programs to ensure product safety and effectiveness for Sanofi's drug delivery devices.
  • The successful candidate will drive user-centered design processes, conduct complex HF studies, and mentor team members while ensuring alignment with FDA and global standards.
  • Sanofi offers a competitive salary range of $148,500.00 - $214,500.00 along with comprehensive benefits including high-quality healthcare and at least 14 weeks' gender-neutral parental leave.

Matching Summary

This role leads Human Factors & Usability Engineering strategy across multiple programs to ensure product safety and effectiveness for Sanofi's drug delivery devices.

Salary

Base: $148,500.00 - $214,500.00; Bonus/Equity: Not specified; Benefits: High-quality healthcare, wellness programs, 14 weeks parental leave

Skills & Requirements

Must-have

  • 10+ years medical device human factors experience
  • Mastery of FDA HF Guidance and IEC 62366-1
  • Lead generative formative summative HF studies
  • Conduct use-related risk analysis (URRA)
  • Manage cross-functional HF/UE programs

Nice-to-have

  • Experience leading FDA submissions and interactions
  • Background in industrial design or instructional design
  • Portfolio-level HF/UE strategy governance
  • Post-market activities knowledge
  • Cross-functional influence across clinical teams

Key Requirements

  • Bachelor's degree in Engineering, Psychology, Industrial Design, or Life Sciences
  • 10+ years progressive experience in medical device human factors engineering
  • Deep expertise in ISO 14971:2019 and ISO 13485 standards

Work Rights

Not specified

Tailored Resume

Cover Letter