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

The Principal Pre-Market Supplier Quality Engineer will lead supplier quality strategy and key deliverables for assigned projects. This role leads supplier quality investigations and nonconformance resolution as well as supplier audits for new or existing suppliers as part of the qualification efforts.
You will develop project plan and timelines to assure a successful project management and product launch.  The Principal Pre-Market Supplier Quality Engineer supports the Supplier selection process and provides Process Validation, Component qualification (PPAP) for components and CM/OEM suppliers.

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.

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

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, Science or technical field  

• Minimum 7 years of work experience in Engineering and/or Quality  
• Or Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality 

Nice to Have 

• 5+ years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise. 

• Advanced knowledge of PPAP process  

• ASQ CQE certification 

• ASQ Lead auditor certification 

• Manufacturing processes or R&D experience 

• Firm understanding of inspection and manufacturing processes (las