Lead Systems Engineer – Risk
About this role
About the Role Lead Systems Engineer – Risk is responsible for leading and overseeing risk management activities across the full lifecycle of medical diagnostic devices at Radiometer, a Danaher operating company. The role reports to the Engineering Manager and is part of the R&D Systems Engineering – PLM team, based at the IDC in Bengaluru East. The role is on-site. What You'll Do
- Lead and oversee risk management activities across the full lifecycle of medical diagnostic devices.
- Ensure that product risks are systematically identified, evaluated, controlled, and monitored in compliance with global regulatory and industry standards.
- Serve as the subject-matter expert on ISO 14971, partnering closely with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Post-Market Surveillance teams to deliver safe, compliant, high-quality products.
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