At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

At Medtronic, we are committed to delivering innovative medical solutions that improve lives. As a Principal Quality Engineer supporting the Neuromodulation business, you will play a critical role in ensuring the quality, safety, and efficacy of our products. Your contributions will help shape life-changing therapies and strengthen Medtronic’s leadership in the medical technology industry.

As a Principal Quality Engineer, you will provide technical expertise and leadership for quality and compliance activities across the product lifecycle, from development to post-market support. You will collaborate closely with cross-functional teams to ensure the highest standards of quality are met.

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’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

Responsibilities may include the following and other duties may be assigned.

• Serve as a technical leader and subject matter expert (SME) in quality engineering, driving continuous improvement and innovation in processes.
• Provide strategic guidance to cross-functional teams on quality and regulatory compliance requirements.
• Collaborate with R&D teams to ensure compliance with design control processes during product development and sustaining engineering efforts.
• Lead risk management activities, including hazard analysis, failure mode and effects analysis (FMEA), own risk management files and drive risk mitigation strategies.
• Own, Plan, Review, evaluate and complete Change Development Process (CDPs), Health Risk Assessment (HRA) and Issue Impact Assessments (IIA)
• Support the Production Part Approval Process (PPAP), Supplier Change Requests (SCRs), Corrections/Removals Assessments, and non-conforming product risk assessments.
• Investigate and resolve complex quality issues using root cause analysis methodologies (e.g., 8D, DMAIC).
• Collaborate with Post Market Surveillance teams to analyze field performance data and ensure timely resolution of product quality issues.
• Lead corrective and preventive actions (CAPA) and drive closure of quality system records.
• Ensure compliance with FDA regulations, ISO 13485, and other applicable global standards.
• Provide support during internal and external audits, including preparation, participation, and follow-up activities.
• Support and complete periodic Risk Management File (RMF) reviews, Regulatory requests, standards gap assessments, complaint investigations, material of concern documentation, and PSURs (Post-Market Surveillance Reports)
• Mentor and coach junior engineers, sharing technical expertise and fostering a culture of quality excellence.

Required Knowledge and Experience: 

• Baccalaureate degree in Engineering, Science, or a related technical field.
• Minimum 7 years of experience in Quality Engineering or a related field within the medical device or regulated industry , or an advanced degree with a minimum of 5 years of experience.

Nice to Have:

• Strong knowledge of FDA regulations, ISO 13485, and risk management standards (ISO 14971).
• Proven expertise in post-market quality and root cause analysis.
• Medical device manufacturing industry experience, preferably ISO 13485.
• Lead auditor experience.
• Certified Quality Engineer (CQE) or Six Sigma Black Belt certification.
• Hands-on experience with post-market surveillance and complaint handling processes.
• Strong project management skills and experience leading cross-functional teams
• Ability to manage tasks and projects under tight deadlines with a sense of urgency.
• Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.
• Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments

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 sk