Principal Supplier Quality Engineer

Medtronic • Brooklyn Park, MN

2d • $120,000 - $180,000 • Onsite

About The Position

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 In this exciting role as a Principal Supplier Quality Engineer in Cardiac Surgery (CS), you will develop supplier quality strategies and lead supplier control activities for new product development programs based in Brooklyn Park, MN and Dexter, MI. Cardiac Surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this operating unit provides an intimate relationship with the Cardiac Surgeon and Cardiac Operating Room by offering an unparalleled depth and breadth of portfolio. Key Technologies: • Surgical heart valves • Cardiac OR solutions (e.g., blood management, cannulae) • Extracorporeal life support • Coronary artery bypass grafting (CABG) solutions 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 are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. Responsibilities may include the following and other duties may be assigned:

Requirements

• Requires a Baccalaureate degree 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
• Prior experience in or demonstrated strong working knowledge of global medical device regulations and requirements
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• Engineering experience with medical devices, specifically disposable devices and/or capital equipment
• Demonstrated experience in managing and executing the Production Part Approval Process (PPAP), including documentation, process validation, and ensuring supplier readiness for production
• Lead Auditor certification from a recognized external body (e.g., ISO 13485 and/or ISO 9001 or equivalent) with experience planning and conducting supplier audits
• Broad knowledge and demonstrated capabilities of project management
• Understanding of heart anatomy and human/blood physiology
• Experience supporting cross-functional and cross-regional teams in a matrixed organization developing collaborative relationships
• Experience with manufacturing assembly processes and inspection/testing method

Responsibilities

• Provide Pre-Market Supplier Quality Engineering support to New Product Development (NPD) working in partnership with the 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
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implement 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
• Manage strategic Contract Manufacturers (CMs) at Medtronic, with accountability for product and process changes, performance oversight, and continuous improvement initiatives
• Ensure that suppliers consistently deliver quality parts, materials, and services
• Lead supplier’s qualification strategy and manage supplier quality deliverables for major/moderately complex projects, involving delegation of work and review of work products
• Manage projects and timelines for supplier deliverables and quality improvements, using structured project management practices to coordinate tasks, track milestones, escalate risks and communicate status clearly to stakeholders
• Manage supplier changes as they evolve during NPD programs, including assessing the impact of changes on existing qualifications and validations
• Develop compliant solutions to moderately complex problems
• Collaborate with suppliers to resolve change-related issues effectively and efficiently, ensuring minimal disruption to program timelines
• Plan and lead supplier audits to qualify suppliers and to assess compliance with regulatory standards and Medtronic Internal procedures including reporting and confirmation of follow-up actions
• Mentor, review and delegate work to lower-level specialists on supplier quality deliverables
• Lead and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products
• Drive cross-functional problem solving and communication with suppliers and internal stakeholders (Sourcing, R&D, Operations, PMO) to resolve issues, align expectations, influence decision making and ensure timely closure of deliverables in compliant fashion
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level