Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Ensure design control compliance and maintain Design History Files (DHF) for new product development.
- Review and approve design documentation, risk analyses (dFMEA, uFMEA, pFMEA), and verification/validation protocols.
- Support change control, impact assessments, and DHF updates.
- Investigate product complaints, lead root cause analyses, and support corrective actions.
- Evaluate product designs for manufacturability, reliability, biocompatibility, and compliance.
- Contribute to new product commercialization and continuous improvement initiatives.
- Support vendor management, audits, and documentation for product release.
Requirements:
- M.S. in Engineering with 3+ years, or B.S. with 5+ years of experience.
- 2 5 years in a regulated medical device environment; experience with combination products preferred.
- Knowledge of ISO 13485, ISO 14971, 21 CFR 820, and cGxP principles.
- Experience with DHF management, risk management, and lifecycle management.
- Strong statistical, technical writing, and communication skills.
- Ability to work independently, manage multiple projects, and collaborate effectively with cross-functional teams.