Lead Reliability Engineer – Post‑Market Quality

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

Benefits offered by this job

Health, Dental and Vision insurance

401(k) plan with employer match

Tuition assistance/reimbursement

Life insurance

Short-term disability

Employee Stock Purchase Plan

Job summary

Medtronic is a global leader in healthcare technology seeking a Principal Reliability Engineer for the Post Market Quality organization. You will provide technical leadership across risk management, post-market surveillance, and FMEA activities to ensure product reliability and patient safety.

The role emphasizes collaboration with design, manufacturing, and quality teams, mentoring junior engineers, and working on-site most days to foster teamwork and project success.

Qualifications

• Requires a Baccalaureate degree in Science, Technology, Engineering, Math or a related technical discipline with a minimum of 7 years of relevant experience.
• Master's degree with a minimum of 5 years relevant experience.
• PhD with 3 years relevant experience.
• Experience in ISO 14971 risk management.
• Strong technical writing and communication skills.
• Proven ability to lead root cause investigations and perform statistical data analysis.

Responsibilities

• Risk Management: Support risk assessments and hazard analyses based on post-market data.
• Lead Health Risk Assessments to determine potential risk and recommend need for Field Corrective Action (FCA).
• Post-Market Surveillance: Monitor product performance in the field, collect and analyze reliability data, and identify trends and potential issues.
• Root Cause Investigation and Failure Analysis: Lead investigations into product failures and complaints, utilizing root cause analysis techniques to determine underlying causes.
• Support complaint trending and investigations of complaint trend excursions or quality signals from the field.
• Design Control: Assess design and risk impacts of changes; generate, review, and approve FMEAs, test method validations, and verification and validation test reports in compliance with medical device design control requirements.
• Continuous Improvement: Collaborate with design, manufacturing, and quality teams to implement design, process or supplier changes, corrective and preventive actions that enhance product reliability.
• Customer Interaction: Provide technical support to customers and field personnel regarding reliability issues and product performance.
• Coaching: Provide technical mentorship and coaching to junior engineers.

Skills

Risk management

Health risk assessments

Post-market surveillance

Root cause investigation

Failure analysis

Statistical data analysis

Technical mentorship

Cross-functional collaboration

Technical writing

Communication skills

Education

Bachelors degree in Science, Technology, Engineering, Math or related

Master's degree

PhD

Job description

Medtronic is a global leader in healthcare technology seeking a Principal Reliability Engineer for the Post Market Quality organization. You will provide technical leadership across risk management, post-market surveillance, and FMEA activities to ensure product reliability and patient safety.

The role emphasizes collaboration with design, manufacturing, and quality teams, mentoring junior engineers, and working on-site most days to foster teamwork and project success.