Katalyst Healthcares and Life Sciences
Responsibilities:
- Lead quality engineering activities for new hardware/software medical device development, including design control and risk management.
- Develop and maintain Risk Management File (RMF), dFMEA, pFMEA, hazards analysis, and risk reports.
- Review/approve Design History File (DHF), design inputs/outputs, verification & validation plans, test protocols, and reports.
- Provide statistical guidance for design verification, validation, and test method validation.
- Act as SME for software quality, including code reviews, cybersecurity, software BOM, and AI/cloud-based solutions.
- Support design transfer, production anomalies, CAPA closure, and quality system updates based on regulations.
- Strong knowledge of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366.
- Experience in medical device hardware, software, and electromechanical systems.
- Skilled with statistical tools (Minitab), Microsoft Office, Adobe Acrobat.
- ASQ CQE and/or Six Sigma Green/Black Belt preferred.
- AI, SaMD, AAMI TIR45, and cloud infrastructure experience a plus.
- B.S./M.S. in Engineering (biomedical, software, electrical, or related).