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. ct 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. Requirements:
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. SQ CQE and/or Six Sigma Green/Black Belt preferred. I, SaMD, AAMI TIR45, and cloud infrastructure experience a plus. B.S./M.S. in Engineering (biomedical, software, electrical, or related).
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. ct 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. Requirements:
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. SQ CQE and/or Six Sigma Green/Black Belt preferred. I, SaMD, AAMI TIR45, and cloud infrastructure experience a plus. B.S./M.S. in Engineering (biomedical, software, electrical, or related).