Job Requirements
Risk Analysis & ManagementLead cross-functional teams in the identification, evaluation, and mitigation of risks across the product lifecycle.Conduct risk assessments (FMEA, UFMEA, Fault Tree, Hazard Analysis) aligned with ISO 14971 and integrate them into the Design History File (DHF).Lifecycle Risk MonitoringMonitor and update risk management files throughout product development, manufacturing, and post-market surveillance.Ensure continuous alignment with emerging risks, field data, and feedback.Regulatory Compliance & DocumentationEnsure full compliance with USFDA 21 CFR Part 820, EU MDR, and other applicable global regulatory requirements.Support DHF/DMR remediation and maintain robust traceability between risk files and design controls.Collaborate with regulatory, quality, and engineering teams to prepare submission-ready documentation.System Engineering SupportApply system engineering principles to assess the integration of hardware, software, and usability aspects into the risk management process.Support product architecture reviews to identify system-level hazards and define safety-critical functions.

Work Experience
Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field.8–10 years of experience in risk management or medical device product development, preferably in a regulated environment.In-depth understanding of:ISO 14971 (Risk Management)ISO 13485 (Quality Management Systems)IEC 60601 (Electrical Safety of Medical Devices)USFDA and EU MDR regulationsProven expertise in preparing and remediating DHF and DMR documentation.Experience with system engineering and risk integration across complex systems (hardware/software).Strong analytical skills, attention to detail, and ability to handle multiple priorities.Excellent communication skills for cross-functional collaboration and regulatory interfacing.