Principal Quality Engineer

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

We anticipate the application window for this opening will close on - 9 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Cardiac Surgery Operating Unit develops and delivers innovative surgical solutions that enable surgeons to treat complex heart conditions, including coronary artery disease, structural heart disease, and cardiopulmonary support needs.

In this exciting role as a Principal Quality Engineer supporting the Post Market Quality organization, you will provide technical leadership across all quality aspects of the commercial portfolio, including Health Risk Assessments, Post Market Surveillance, and Risk Management. You will serve as a key partner to cross functional teams, guiding critical quality decisions that protect patients and ensure sustained product performance.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

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.

Nice to Haves - Preferred Qualifications

• Prior experience in the medical device industry across product development, operations, or quality functions.
• Demonstrated expertise in risk management in accordance with ISO 14971.
• Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiences.
• Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis.

Must Haves: Required Qualifications

• Requires a Baccalaureate 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

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the