Risk Management Engineer, Quality - Defined Term

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Date:
Oct 2, 2026

Location:

Fraser, MI, US

Remote Work: 1-2 days at home (site based)

Salary Range: $96,240-$120,300 per year

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

The primary purpose of this position is to establish, maintain, and continuously improve product and process risk management activities throughout the medical device lifecycle. The Risk Management Engineer serves as the subject matter expert for ISO 14971 risk management processes and is responsible for development and maintenance of Risk Management Files (RMFs), hazard analyses, risk assessments, and risk-related documentation to ensure compliance with applicable regulatory requirements and company procedures.

This role partners closely with Engineering, Sustaining Engineering, Quality, Regulatory Affairs, Operations, Clinical Affairs, and Supply Chain functions to ensure product risks are appropriately identified, evaluated, controlled, and monitored throughout the product lifecycle.

This is a "Defined Term" assignment that will last approximately 12 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.

• Perform all activities in compliance with the Quality Management System (QMS), FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, and other applicable regulatory requirements.
• Establish, maintain, remediate, and continuously improve Risk Management Files for medical devices throughout product development and commercialization.
• Lead product risk assessments including Hazard Analysis, Design FMEA (dFMEA), Process FMEA (pFMEA), Use-Related Risk Analysis, and post-market risk evaluations.
• Facilitate cross-functional risk management activities with Engineering, Sustaining Engineering, Quality, Regulatory Affairs, Operations, Clinical Affairs, and Supply Chain.
• Identify hazards, foreseeable misuse, hazardous situations, and potential harms associated with medical devices.
• Evaluate risk acceptability and ensure implementation of appropriate risk control measures.
• Verify and document effectiveness of risk control measures and residual risk acceptability.
• Ensure traceability between identified hazards, risk controls, design requirements, verification activities, complaints, CAPAs, and post-market surveillance data.
• May participate in complaint investigations, nonconformance investigations, CAPAs, supplier quality issues, and root cause analysis activities to assess product risk impacts.
• Monitor post-market surveillance data including complaints, customer feedback, nonconformities, service reports, and adverse events to identify emerging risks.
• Support internal, external, FDA, Notified Body, and corporate audits related to risk management documentation and processes.
• Develop and deliver risk management training to employees across the organization.
• Support the development and maintenance of risk management procedures, work instructions, and templates.
• Assist management with ongoing quality improvement initiatives and risk-based decision-making activities.
• May be required to perform other duties as assigned or as needed.

• Proficiency in technical documentation and oral and written…