Principal Reliability Engineer: Post-Market Quality & Risk

Medtronic; Mounds View (MN); On-site; USD 132,000 - 198,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with employer match

Tuition assistance/reimbursement

Paid time off and holidays

Employee Stock Purchase Plan

Well-being programs

Job summary

Medtronic's Cardiac Surgery Operating Unit seeks a Principal Reliability Engineer to lead post-market quality activities and risk management across the portfolio.

You will guide health risk assessments, post-market surveillance, and root cause investigations while partnering with cross-functional teams to protect patients and ensure sustained product performance. Onsite four days a week with limited travel.

Qualifications

• Bachelor's degree in a technical field with 7+ years of relevant experience or Master’s/PhD with applicable experience.
• Demonstrated expertise in ISO 14971 and risk management for medical devices.
• Proven ability to lead root cause investigations and analyze reliability data.

Responsibilities

• Lead risk assessments and health risk analyses based on post-market data.
• Oversee Post-Market Surveillance to identify trends and issues.
• Drive root cause investigations and corrective actions for field issues.
• Assess design changes, approve FMEAs and validation reports per design control.
• Collaborate with cross-functional teams to implement improvements.
• Provide technical mentorship and support to colleagues and customers.

Skills

Risk management

ISO 14971

Root cause analysis

Statistical data analysis

Technical writing

Education

Bachelor's degree in Science/Engineering/Math

Master's degree with 5+ years relevant experience

PhD with 3 years relevant experience

Tools

FMEA

Job description

Medtronic's Cardiac Surgery Operating Unit seeks a Principal Reliability Engineer to lead post-market quality activities and risk management across the portfolio.

You will guide health risk assessments, post-market surveillance, and root cause investigations while partnering with cross-functional teams to protect patients and ensure sustained product performance. Onsite four days a week with limited travel.