Mid-Senior level
Posted March 26, 2026
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Responsibilities
Commitments
Responsibilities
- 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 .
- The role involves collaborating with cross-functional teams to identify product risks, implement controls, and ensure compliance with global medical device regulations.
- 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
Commitments
Role: Senior Risk / Reliability Engineer – Medical Devices Location: Minneapolis / Fridley, Minnesota (Fully Onsite, Remote Fridays) Type: W2 Contract Duration: May 2026 – Dec 2026 Note: Medical device industry background is required.
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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
Role: Senior Risk / Reliability Engineer – Medical Devices Location: Minneapolis / Fridley, Minnesota (Fully Onsite, Remote Fridays) Type: W2 Contract Duration: May 2026 – Dec 2026 Note: Medical device industry background is required. 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 . The role involves collaborating with cross-functional teams to identify product risks, implement controls, and ensure compliance with global medical device regulations. Key Skills & Experience
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
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