Senior Medical Device Reliability Engineer — Post‑Market

Medtronic plc; Mounds View (MN); Hybrid; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company match

Employee stock purchase plan

Job summary

Medtronic plc in Minnesota seeks a Senior Reliability Engineer to support post-market surveillance for implantable devices. You will analyze performance data, support risk assessments, and help investigate quality issues to improve product reliability for pacemakers, defibrillators, and leads.

The role requires strong background in reliability, risk management, and regulatory standards (21 CFR 820, ISO 13485, ISO 14971). Hybrid on-site work in Mounds View, MN with 4+ days/week onsite.

Qualifications

• Bachelor’s degree in engineering, science, or a technical discipline with 4+ years of related experience, or 2+ years with advanced degree.
• Experience in reliability engineering or risk management.
• Experience with 21 CFR 820, ISO 13485, and ISO 14971.
• Experience with Class III medical devices, RF or regulatory requirements.

Responsibilities

• Support reliability and engineering activities to analyze, debug, and recommend design or process changes that improve system and process reliability.
• Assist with risk analysis studies of designs and processes to understand how potential quality issues may contribute to product quality or patient safety risk.
• Author or support the preparation of risk assessments, technical reports, and documentation of analysis results or quality impact.
• May fulfill the role of “Personnel with Clinical Knowledge” in risk management assessments if specialized skill criteria is met.
• Support verification and validation of device system requirements, including traceability and testability.
• Conduct or support evaluation of finished product systems, including requirements, design, development, documentation, integration, test, verification, and validation.
• Interpret and decompose system and product requirements and verify compliance with applicable standards and specifications.
• Collaborate with cross-functional partners to help investigate quality issues and support corrective actions.
• Analyze product performance data and summarize findings to support post-market surveillance and product improvement activities.

Skills

Reliability engineering

Risk management

Root cause investigations

Data analysis

Education

Bachelor’s degree in engineering/science/technical discipline

Advanced degree (MS/PhD)

Job description

Medtronic plc in Minnesota seeks a Senior Reliability Engineer to support post-market surveillance for implantable devices. You will analyze performance data, support risk assessments, and help investigate quality issues to improve product reliability for pacemakers, defibrillators, and leads.

The role requires strong background in reliability, risk management, and regulatory standards (21 CFR 820, ISO 13485, ISO 14971). Hybrid on-site work in Mounds View, MN with 4+ days/week onsite.