Lead Systems Engineer – Risk

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Radiometer one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Radiometer life comes first. Our vision is to improve global healthcare with reliable fast and easy patient diagnoses. Were a team that celebrates diverse ideas and continuous improvement. Here youll find a place to grow and make a real impact with your unique perspective driving us forward in improving patient care. At Radiometer our vision is to improve global healthcare with reliable fast and easy patient diagnoses.

Learn about the Danaher Business System which makes everything possible.

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 on-site.

In this role you will have the opportunity to:

• 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.

The essential requirements of the job include:

• A bachelors 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 strong 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 clear 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.

It would be a plus if you also possess previous experience in:

• 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.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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