Key Skills: ISO 13485, Risk And Control, ISO 14971, Risk Assessment, System Engineer, Risk Management, Threat Analysis, Certification
Roles and Responsibilities:
Lead risk management to ensure requirements address identified hazards, mitigations, and residual risk acceptance.
Lead FMEA/FMECA activities and ensure results flow into requirements and verification.
Structure and decompose system requirements for electromechanical medical device development projects.
Maintain bidirectional traceability linking requirements to risk controls, architecture/design elements, and verification methods.
Facilitate cross-functional requirement reviews to ensure clarity, feasibility, and compliance with ISO 13485 and ISO 14971.
Skills Required:
12-16 years of experience in Systems Engineering and Risk Management.
Strong experience in Risk Assessment and Risk Management.
Experience in Threat Analysis and FMEA/FMECA.
Strong knowledge of ISO 13485 and ISO 14971.
Experience with requirements engineering and traceability.
Valuable to Have
Medical Device Risk Management certification.
Experience in medical device development and certification.
Education: Any Graduation (Engineering preferred)

📌 Principal Engineer (Bengaluru)
🏢 MyCareernet
📍 Bengaluru