Senior Medical Device Risk Manager - NPI & Design Control

GE HEALTHCARE DANMARK A/S; Herlev Kommune; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

GE HealthCare Danmark A/S seeks a Senior Risk Management Specialist to drive risk activities across the full product lifecycle, supporting safety, quality and regulatory compliance. You will facilitate risk assessments, xFMEA, and ensure risk outputs are integrated into design controls and verification, with strong cross-functional collaboration.

As a senior contributor, you will maintain risk documentation, tie risks to requirements, and take part in continuous improvement of risk methods,

Qualifications

• Relevant engineering degree and senior-level risk management experience.
• Solid understanding of ISO 14971, Design Control and regulated product development.
• Experience applying risk management through risk assessments and xFMEA activities.

Responsibilities

• Lead risk management activities across the full product lifecycle.
• Facilitate risk assessments and xFMEA with cross-functional teams.
• Develop and maintain Risk Management Plans, Assessments and Reports.
• Ensure integration of risk activities with Design Control and verification.
• Maintain traceability between risks, mitigations, requirements, and verifications.
• Incorporate field data, CAPA and post-market information into risk assessments.
• Contribute to continuous improvement of risk management processes.

Skills

Risk Management

Systems Engineering

Product Development

Regulated Industries

Technical Writing

Education

Engineering degree

Tools

xFMEA

Risk Management Tools

Traceability

Job description

GE HealthCare Danmark A/S seeks a Senior Risk Management Specialist to drive risk activities across the full product lifecycle, supporting safety, quality and regulatory compliance. You will facilitate risk assessments, xFMEA, and ensure risk outputs are integrated into design controls and verification, with strong cross-functional collaboration.

As a senior contributor, you will maintain risk documentation, tie risks to requirements, and take part in continuous improvement of risk methods,