Risk Manager / FMEA Specialist

Primary Function: Owns risk management documentation and facilitates integration of risk-related updates within the DHF, including FMEA updates and risk matrix revisions. Key Responsibilities: · Update or contribute to Design and Process FMEAs in alignment with DHF updates · Maintain and revise risk management files and risk traceability matrices · Collaborate with onshore and offshore teams to ensure risks are adequately mitigated and documented · Participate in or facilitate risk review sessions · Ensure consistency with ISO 14971 and internal risk management processes Location Requirement: Candidate must be based in Pune, India or willing to relocate. Working Hours Requirement: ⏰ Candidate must be available to work until 12:00 PM Eastern Time (ET) to coordinate with US-based team members. Qualifications: · 4–7 years in Risk Management or Regulatory Engineering for medical devices · Hands-on experience with FMEA (Design & Process), hazard analysis, and risk documentation · Deep understanding of ISO 14971 and MDR risk requirements · Experience with team-based risk sessions and traceability documentation

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