Principal Supplier Quality Engineer

About the role

The Principal Supplier Quality Engineer for New Product Development (NPD) within the CardioVascular Surgery Operating Unit (OU) is responsible for driving supplier quality excellence to support the successful development and launch of innovative Aortic devices. This role collaborates with cross-functional teams and suppliers to ensure robust component development, qualification, and release processes that align with program timelines and regulatory requirements.

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
• 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
• Manage strategic Contract Manufacturers (CMs) at Medtronic, with accountability for product and process changes, performance oversight, and continuous improvement initiatives
• Lead supplier’s qualification strategy and managing 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 provides feedback in assessment of their operation
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods

Requirements

• Requires a Baccalaureate degree AND 7+ years of relevant experience OR Master's degree with 5+ years relevant experience OR PhD with 3 years relevant experience
• Experience with global medical device regulations and requirements
• Experience with global medical device regulations and requirements
• Must have a valid U.S. work authorization

Qualifications

• Engineering experience with medical devices, specifically disposable devices and/or capital equipment
• Experience 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)
• Demonstrated capabilities of project management
• Understanding of heart anatomy and human/blood physiology
• Experience supporting cross-functional and cross-regional teams in a matrixed org. developing collaborative relationships
• Experience with manufacturing assembly processes and inspection/testing methods

Skills

• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to manage multiple priorities and deadlines
• Strong organizational and time management skills
• Ability to work independently and as part of a team

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package including:

• 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
• Employee Stock Purchase Plan
• Employee Assistance Program
• Simple Steps (global well-being program)

Pay

$123,200.00 - $184,800.00

Schedule

Less than 10% travel is required