Senior Risk Management Specialist Medical Devices

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

Placering
Herlev

Job Description Summary
As a Senior Risk Management Specialist, you will drive risk management activities across the full product lifecycle, supporting product safety, quality, and regulatory compliance within cross-functional product development teams. You will facilitate risk assessments, support xFMEA activities, evaluate hazards and risk controls and ensure that risk management outputs are effectively implemented and maintained. Working at the intersection of Risk Management, Systems Engineering, and Design Control, you will ensure alignment between requirements, risk controls, verification activities, and traceability across new product development and sustaining engineering. You apply sound judgement to help teams make informed decisions balancing product development needs with risk management requirements. You contribute to the continuous improvement of risk management methodologies and tools.

For this role, you must be eligible to work in Denmark and located within reasonable commuting distance of our facilities in Herlev, near Copenhagen.

Job Description
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Essential Responsibilities:

• Support New Product Introduction (NPI) and sustaining engineering activities throughout the product lifecycle.
• Facilitate risk assessments and xFMEA activities in collaboration with subject matter experts across engineering, clinical, manufacturing, service, and other lifecycle disciplines.
• Develop and maintain Risk Management Plans, Risk Assessments, Risk Management Reports, and related risk management documentation.
• Support development and maintenance of requirements, specifications, verification plans, verification documentation, and other Design Control deliverables as appropriate.
• Ensure effective integration of risk management activities into Design Control, verification, validation, and change management processes.
• Maintain traceability between risks, mitigations, requirements, and verification evidence.
• Integrate field experience, customer complaints, CAPA investigations, clinical evaluations, product changes, and post-market surveillance information into product risk assessments and risk management documentation.
• Contribute to continuous improvement of risk management methodologies, templates, tools, and best practices.
  

Required Qualifications:

• Relevant Engineering degree.
• Senior-level experience in Risk Management, Systems Engineering, and Product Development within medical devices or another regulated industry.
• Solid understanding of ISO 14971, Design Control, Change Control, and regulated product development.
• Practical experience applying Risk Management principles through risk assessments and xFMEA activities.
• Experience working with complex products requiring collaboration across software, electrical, mechanical, clinical, manufacturing, and service disciplines.
• Familiarity with requirements development, specification writing, traceability, verification planning, and verification summaries.
• Strong technical writing, communication, and stakeholder collaboration skills.

Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Inclusion & Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.
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Additional Information
Relocation Assistance Provided: No