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 push the boundaries of medical technology to transform the way healthcare is delivered and improve the lives of millions. As a Senior Principal Quality Engineer in the Neuromodulation business, you will play a pivotal role in ensuring the highest standards of quality and compliance for life-changing therapies. This is your opportunity to join a global leader in medical technology and make a lasting impact.

As a Senior Principal Quality Engineer, you will lead quality initiatives and play a key role in post-market, manufacturing and product development activities for the Neuromodulation business.

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.
• Support 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 to build organizational capability and foster a culture of quality excellence.

Required Knowledge and Experience: 

• Requires a Baccalaureate degree in Engineering, Science, or a related technical field.
• Minimum of 10 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 8 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 skills of this position. 

The physical demands described within the Responsibilities section of this j