Job Summary

The 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. This position 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 in office.

Responsibilities
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.

Essential requirements
A bachelor s degree in Engineering or Science, along with a mandatory ISO 14971 Risk Management certification from a recognized, accredited organization.
10+ years of hands-on experience in Medtech development, with solid expertise in Risk Management and Systems Engineering.




Proven ability to lead and execute end-to-end risk management activities, including developing, maintaining, and approving risk management plans, analyses, benefit-risk assessments, and evaluation reports, while guiding cross-functional hazard identification, risk analysis, and risk control across product development and sustaining phases.
Experience supporting regulatory submissions, audits, and health authority interactions by providing transparent, risk-based rationale and documentation.
Ability to partner with Post-Market Surveillance, Vigilance, and Complaint Handling teams to evaluate field data and update risk documentation as required.

Preferred qualifications
Hands-on use of lifecycle management or systems engineering tools (e.g., Polarion or equivalent).
Working knowledge of ISO 13485 and IEC 62366, with a strong emphasis on integrating usability engineering into risk management practices.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Lead Systems Engineer Risk Karnataka
🏢 DHR Holding India
📍 Karnataka