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Senior Reliability Engineer

LinkedIn Grove Technical Resources, INC Minneapolis, MN
Mid-Senior level Posted March 26, 2026 Job link
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Requirements
  • We are seeking a Senior Risk / Reliability Engineer with strong experience in medical device risk management to support sustaining activities for Class III implantable medical devices .
  • 5+ years experience in medical device industry
  • Strong expertise in ISO 14971 Risk Management
  • Experience maintaining Risk Management Files
  • Knowledge of hazard analysis, FMEA, product hazard analysis
  • Experience with Design Controls (Verification, Validation, Design Transfer)
  • Familiarity with FDA 21 CFR 820, ISO 13485, EU MDR
  • Experience with implantable medical devices
  • Statistical analysis and reliability engineering knowledge
  • Cross-functional collaboration with Design, Human Factors, Medical Safety, and Quality teams Responsibilities
  • Maintain and update risk management documentation for Class III devices
  • Identify hazards, evaluate risks, and implement risk control strategies
  • Support design control deliverables and product safety validation
  • Conduct risk reviews and support regulatory compliance
  • Partner with engineering and quality teams to improve product reliability and patient safety Nice to Have
  • Data analytics experience
  • Strong leadership and problem-solving skills
Preferred Skills
  • Familiarity with FDA 21 CFR 820, ISO 13485, EU MDR
  • Experience with implantable medical devices
  • Statistical analysis and reliability engineering knowledge