Hfue Associate Director

Sanofi

Morristown, NJ, US
Base: $148,500.00 - $214,500.00; bonus/equity: not...
10+ years medical device experience
Fda hf guidance mastery
Iec 62366-1 and iso 14971 expertise
This role leads Human Factors & Usability Engineering strategy across multiple programs to ensure product safety and effectiveness

Job Summary

  • This role leads Human Factors & Usability Engineering strategy across multiple programs to ensure product safety and effectiveness.
  • The successful candidate will drive user-centered design processes from early research through lifecycle management while mentoring team members.
  • Sanofi offers a competitive salary range of $148,500-$214,500 along with extensive benefits including 14 weeks of gender-neutral parental leave.

Matching Summary

This role leads Human Factors & Usability Engineering strategy across multiple programs to ensure product safety and effectiveness.

Salary

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

Skills & Requirements

Must-have

  • 10+ years medical device experience
  • FDA HF Guidance mastery
  • IEC 62366-1 and ISO 14971 expertise
  • Generative and summative study leadership
  • Use-related risk analysis (URRA)
  • Cross-functional team mentorship

Nice-to-have

  • Masters degree in related field
  • Experience with IFU instructional design
  • Portfolio-level strategy governance
  • FDA submission interaction experience
  • Background in clinical practice or post-market activities

Key Requirements

  • Bachelor's degree in Engineering, Psychology, or Life Sciences
  • 10+ years progressive experience in human factors engineering
  • Mastery of FDA guidance and IEC/ISO standards
  • Willingness to travel up to 20%

Work Rights

Not specified

Tailored Resume

Cover Letter