Careers that Change Lives

A career at Medtronic is like no other. We're committed to and driven by our mission to alleviate pain, restore health, and extend life for millions of people worldwide!

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

A Day in the Life

Medtronic is currently searching for a Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You'll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities.

Key Responsibilities:

• Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.
• Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
• Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits.
• Evaluate suppliers' internal functions to assess overall performance and provide feedback.
• Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization).
• Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting.
• Manage the Approved Supplier List, including administrative work in MAP Agile.
• Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
• Improve suppliers' performance and reduce escapes to manufacturing.
• Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development.
• Knowledgeable in Statistical analysis (MSA, Capability, SPC)
• Support DFMEA and PFMEA activities
• Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team
• Design Transfer; translating design specifications into production specifications.
• Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.
• Provide mentorship and coaching.
• T he job requires occasional travel to visit suppliers within the United States and internationally.

• Bachelors degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice to Have

• Medical device manufacturing industry experience, preferably ISO 13485.
• Lead auditor experience.
• Hands-on experience with SAP, Trackwise, Agile change management.
• 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.
• Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.
• Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.
• Engage in changes and advocate for inclusion/diversity.
• Experience with materials and manufacturing processes such as PCBAs, MIM, nitinol, cables, crimping, laser welding, automated functional testing
• DRM or DFSS
• Knowledge of GD&T

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here .

The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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 employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)