Risk Management Engineer – Med Devices (Hybrid/Remote)

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

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.