Senior Quality Engineer, Medical Devices (Onsite 4x/Week)

Medtronic; Mounds View (MN); On-site; USD 120,000 - 180,000; Full time

Job summary

Medtronic in Minnesota is seeking a Principal Quality Engineer to lead post-market quality activities across the commercial portfolio, including health risk assessments, post-market surveillance, and risk management. You will partner with cross-functional teams to guide critical quality decisions that protect patients and ensure sustained product performance.

The role requires a baccalaureate in a technical field with extensive experience; in-person collaboration is emphasized with onsite work

Qualifications

• Bachelor's degree in Science, Technology, Engineering, Math or a related technical discipline with a minimum of 7 years of relevant experience.
• OR Master's degree with a minimum of 5 years relevant experience
• OR PhD with 3 years relevant experience

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

Post-market quality

Root cause analysis

Statistical data analysis

Technical writing

Cross-functional collaboration

Mentoring

Education

Bachelor of Science/Engineering

Master's degree

PhD

Job description

Medtronic in Minnesota is seeking a Principal Quality Engineer to lead post-market quality activities across the commercial portfolio, including health risk assessments, post-market surveillance, and risk management. You will partner with cross-functional teams to guide critical quality decisions that protect patients and ensure sustained product performance.

The role requires a baccalaureate in a technical field with extensive experience; in-person collaboration is emphasized with onsite work