We anticipate the application window for this opening will close on - 17 Dec 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

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. 

In this exciting role as a Principal Supplier Quality Engineer, you will have responsibility for management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team. You will have responsibility for and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness.  Coordinate feedback of quality indicators and statistics to business team for use in business decisions.  Perform, direct, or consult in supplier validations.  QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. 

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

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

• Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.

• Execute Product Qualification activities ensuring suppliers are capable of delivering quality products and materials. 

• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.

• Execute Product Acceptance Strategy and associated test method validation at suppliers.

• Evaluate suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

• Develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, and Supplier Owned Quality deployment for transferred products.

Must Have: Minimum Requirements:

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

• Requires a Bachelors degree in Engineering, Science or Technical field and 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.

Nice to Have

• Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience.  May have deep knowledge of project management.

• Supplier Controls process knowledge and experience, including creation and maintenance of supplier files in the approved supplier list (ASL)

• Experience in Windchill and Agile PLM systems

• Working knowledge of FDA regulations and ISO standards applicable to implantable and non-implantable medical devices

• ASQ CQE, CQA and/or CSQP certification

• First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified

• Knowledge with PPAP process and part/product validation and qualification

• Strong knowledge of metrology & measurement techniques; statistical analysis (e.g. Ppk/Cpk, standard deviation, correlation) in Minitab, measurement uncertainty, GD&T, Gauge Repeatability & Reproducibility

• Demonstrated track record of effectively influencing and negotiating with suppliers and leading effective/successful change initiatives

• Skilled in project leadership practices, including ability to balance risk and benefit, effectively influence diverse teams, and ownership of responsibility for outcomes.

• Excellent downward, lateral, and upward communication skills

• Strong organizational and presentation skills

• Good balance of high level strategic and detailed tactica