What are the responsibilities and job description for the Sr Risk Engineer / Sr Reliability Engineer – Medical Device position at Grove Technical Resources?
Hiring: Sr Risk Engineer / Sr Reliability Engineer – Medical Device
Location: Fridley, MN (4 Days Onsite / 1 Day Remote)
Type: W2 Contract | Duration: 1 Year
We are seeking a Sr Risk Engineer with strong experience in Medical Device Risk Management and Design Quality.
Key Skills Required:
ISO 14971 Risk Management
Risk Management Files (RMF) Maintenance
Hazard Analysis, FMEA & Risk Assessments
Design Controls (Verification, Validation & Transfer)
FDA 21 CFR 820, ISO 13485 & EU MDR
Implantable Medical Devices
Statistics & Reliability Engineering
Cross-functional collaboration with Design, Human Factors, Quality & Reliability teams
Responsibilities:
Create, update, and maintain Risk Management Files for Class III Medical Devices
Ensure risk controls are identified, implemented, verified, and validated
Conduct hazard analyses, risk assessments, and FMEA activities
Collaborate with cross-functional teams to ensure product safety, performance, and regulatory compliance
Support continuous improvement of risk management processes
Requirements:
A biomedical engineering background is preferred
3 years of Medical Device Risk Management experience
3 years working with ISO 14971 and Design Control deliverables
Experience with implantable medical devices strongly preferred
Interested candidates, please share your updated resume.