Human Factors Expert

Argenx

Multiple Locations
**
Human factors engineering (hfe)
Usability studies
Prefilled syringes and autoinjectors
** Argenx is seeking a Human Factors Expert to contribute to the development of drug/device combination products, ensuring they are user-friendly and meet regulatory standards. The ideal candidate will have substantial experience in human factors engineering and usability studies, particularly concerning delivery systems like prefilled syringes and autoinjectors. **

Job Summary

  • Join argenx in the development of drug/device combination products, focusing on human factors engineering and usability studies for prefilled syringes, autoinjectors, and related delivery systems.
  • Key responsibilities include strategizing and leading HFE activities, developing study plans, conducting task analyses and risk assessments, and preparing documentation for regulatory submissions.
  • Ensure compliance with FDA guidance on human factors, ISO 62366, and other relevant standards while collaborating with cross-functional teams.

Matching Summary

Match Score: 75

** Argenx is seeking a Human Factors Expert to contribute to the development of drug/device combination products, ensuring they are user-friendly and meet regulatory standards. The ideal candidate will have substantial experience in human factors engineering and usability studies, particularly concerning delivery systems like prefilled syringes and autoinjectors. **

Skills & Requirements

Must-have

  • Human Factors Engineering (HFE)
  • Usability studies
  • Prefilled syringes and autoinjectors
  • Combination product development
  • Regulatory submissions (FDA, EMA)

Nice-to-have

  • Experience with autoinjector platforms
  • Device usability for chronic conditions

Key Requirements

  • Proven track record in human factors/usability engineering
  • Project management and cross-functional leadership
  • Deep understanding of combination product development
  • Familiarity with global regulatory frameworks

Work Rights

Not specified

Tailored Resume

Cover Letter