Senior Human Factors Engineer

Abbott

Galway, Ireland
Base: not specified; bonus/equity: not specified; ...
6+ years medical device usability studies
Iec 62366-1 and iso 14971 standards
Fda human factors engineering reports
The Senior Human Factors Engineer leads the planning and execution of formative and summative usability studies for rapid diagnostic products across global markets

Job Summary

  • The Senior Human Factors Engineer leads the planning and execution of formative and summative usability studies for rapid diagnostic products across global markets.
  • This role is critical for generating high-quality usability evidence and documentation required for FDA submissions, IVDR compliance, and WHO Prequalification filings.
  • Candidates must possess advanced knowledge of cognitive psychology and human-system interaction to mitigate use-related risks in a fast-paced matrixed environment.

Matching Summary

The Senior Human Factors Engineer leads the planning and execution of formative and summative usability studies for rapid diagnostic products across global markets.

Salary

Base: Not specified; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 6+ years medical device usability studies
  • IEC 62366-1 and ISO 14971 standards
  • FDA Human Factors Engineering Reports
  • IVDR GSPR usability justification
  • WHO PQDx submission experience

Nice-to-have

  • Mentorship of junior team members
  • Cross-functional collaboration skills
  • Experience with lateral flow diagnostics
  • Travel up to 25% internationally

Key Requirements

  • 6+ years planning and moderating usability studies
  • Experience preparing HFER for FDA submissions
  • Strong working knowledge of IEC 62366-1 and ISO 14971
  • Hands-on experience with point-of-care diagnostic devices

Work Rights

Not specified

Tailored Resume

Cover Letter