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).