This is your chance to drive impactful innovation by leading usability studies, guiding risk analysis, and collaborating cross-functionally across R&D, Regulatory, and Marketing teams.
Responsibilities :
- Lead formative and summative usability studies for medical devices.
- Develop detailed usability and risk analysis reports (IEC 62366-1, ISO 14971, etc.).
- Manage human factors deliverables throughout the product lifecycle.
- Partner with cross-functional teams to ensure safe and effective device design.
- Stay ahead of evolving FDA guidance and compliance requirements.
Requirements :
8+ years in human factors / usability engineering.
Strong command of HFE standards and regulatory frameworks (21 CFR Part 820.30, ANSI HE75).
Proven leadership in human factors for medical device development.
Skilled communicator and collaborator across disciplines.
