We anticipate the application window for this opening will close on - 5 Sep 2025

 

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

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 Sr. 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.
• Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred.
• 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.
• The job requires occasional travel to visit suppliers within the United States and internationally.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree in engineering or related field
• Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years relevant experience

Nice to Have:

• Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred
• 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

About Medtronic

Together, we can change healthcare worldwide. At Medtronic,