Lead Systems Engineer – Risk

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 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 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, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.