Katalyst Healthcares and Life Sciences
Job Description:
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:
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.
- 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.