Risk Management Engineer, Quality - Defined Term

Getinge; Fraser (MI); Hybrid; USD 96,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401k with company match

Paid Time Off

Tuition reimbursement

Job summary

Getinge is seeking a Risk Management Engineer, Quality, Defined Term, in Fraser, MI. The role focuses on establishing and improving ISO 14971 risk management activities across the product lifecycle.

You will develop RMFs, perform hazard analyses, and lead cross-functional risk assessments with Engineering, Quality, and Regulatory Affairs. The position is a defined-term assignment (~12 months) with eligibility for most benefits, including health insurance and paid time off while on assignment.

Qualifications

• Bachelor's degree with 5+ years of experience in medical device manufacturing, product development, quality engineering, or risk management.
• Master's degree with 3+ years of experience in medical device manufacturing, product development, quality engineering, or risk management.

Responsibilities

• Establish, maintain, and improve Risk Management Files for medical devices throughout product development and commercialization.
• Lead product risk assessments including Hazard Analysis, DFMEA, PFMEA, UFMEA, and risk-benefit assessments.
• Facilitate cross-functional risk management activities with Engineering, Quality, Regulatory Affairs, Operations, and Supply Chain.
• Identify hazards, foresee misuse, and evaluate risk controls; ensure traceability across RMF, design requirements, verification, and post-market data.
• Support audits related to risk management documentation and processes.
• Develop and deliver risk management training to employees across the organization.

Skills

Risk management

Regulatory knowledge

Cross-functional collaboration

Documentation

Communication

Attention to detail

MS Office

eQMS

Education

Bachelor's degree in Engineering/ Biomedical Engineering/ Quality/ Life Sciences or related discipline

Master's degree in Engineering/ Biomedical Engineering/ Quality/ Life Sciences or related discipline

Tools

MS Office

eQMS

Job description

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Risk Management Engineer, Quality - Defined Term

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.

Job Overview

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.

Job Responsibilities and Essential Duties

• 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.

Required Knowledge, Skills and Abilities

• Proficiency in technical documentation and oral and written communication skills
• Knowledge of medical device regulatory requirements, including FDA 21CFR 820, ISO 9001:2015, ISO 13485:2016, etc. Medical device experience highly preferred.
• Strong knowledge of ISO 14971 medical device risk management principles and methodologies.
• Experience facilitating and documenting DFMEA, PFMEA, UFMEA, Hazard Analysis, Fault Tree Analysis (FTA), and risk-benefit assessments.
• Strong knowledge in regulatory requirements for the medical device industry, particularly working experience in design control.
• Capable of effectively interfacing with cross-functional team members in achieving common goals.
• Attention to detail and high level of accuracy.
• Good organizational skills and the ability to handle multiple projects at once.
• Proficiency with Microsoft Office applications and electronic quality management systems (eQMS).
• Requires a Bachelor's degree in Engineering, Biomedical Engineering, Quality, Life Sciences, or a related technical discipline with 5+ years of experience in medical device manufacturing, product development, quality engineering, or risk management.

OR

• Requires a Master's degree in Engineering, Biomedical Engineering, Quality, Life Sciences, or a related technical discipline with 3+ years of experience in medical device manufacturing, product development, quality engineering, or risk management.

Quality Requirements

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions

• Standing and or sitting for long periods of time.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The salary range for this position is between $96,240-$120,300 per year depending on experience

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.