Associate Director, Human Factors Design And Development

CSL Limited

Human factors engineering experience
Medical device development background
Formative and summative usability studies
This role leads the integration of human factors engineering to ensure medical products are safe, effective, and user-friendly

Job Summary

  • This role leads the integration of human factors engineering to ensure medical products are safe, effective, and user-friendly.
  • The position requires conducting formative and summative usability studies while preparing HF-related sections for global regulatory submissions.
  • Candidates will mentor junior staff and collaborate with cross-functional teams including Design, Engineering, Regulatory Affairs, and Quality.

Matching Summary

This role leads the integration of human factors engineering to ensure medical products are safe, effective, and user-friendly.

Skills & Requirements

Must-have

  • Human Factors Engineering experience
  • Medical device development background
  • Formative and summative usability studies
  • ISO 14971 risk management knowledge
  • IEC 62366 standards expertise
  • FDA and EU MDR regulatory submissions

Nice-to-have

  • Cross-functional team leadership
  • Mentoring junior staff members
  • Global strategy implementation
  • Innovation culture appreciation

Key Requirements

  • Master's or PhD in Human Factors or related field
  • 8-12 years of experience in human factors engineering
  • Proven experience with medical device usability studies
  • Expertise in IEC 62366 and ISO 14971 standards

Work Rights

Not specified

Tailored Resume

Cover Letter