Senior Supplier Quality Engineer

About the role

The Senior Supplier Quality Engineer for New Product Development (NPD) within the CardioVascular Surgery Operating Unit (OU) is responsible for executing supplier quality activities that support the successful development and launch of innovative cardiac surgery devices. This role works closely with cross-functional teams and suppliers to ensure effective component development, qualification, and release processes that align with program timelines and regulatory requirements.

Responsibilities

• Provide 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
• Drive supplier qualification activities including process development reviews, capability assessments, and readiness evaluations for new components and materials
• Lead and approve PPAP (Production Part Approval Process) activities, ensuring completeness, technical adequacy, and alignment with Medtronic quality standards
• Ensure that suppliers consistently deliver quality parts, materials, and services
• Assess and manage supplier changes during NPD and early commercialization phases, evaluating the impact to existing qualifications, validations, and product risk profiles
• 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
• Execute and support the implementation of Product Acceptance Sampling strategies, coordinate Approved Supplier List (ASL) activities, and deploy Supplier Owned Quality and Control Plans for new products in alignment with established supplier quality strategies
• Partner with R&D, Manufacturing Engineering, Regulatory and Sourcing teams to ensure supplier processes and components meet design intent, quality requirements and manufacturability expectations
• Lead supplier issue resolution using structured problem-solving methodologies and ensure timely implementation of corrective and preventive actions
• 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

Requirements

• Nice to haves - Preferred Qualifications: Engineering experience within the medical device industry, specifically disposable devices and/or capital equipment; Working knowledge of Production Part Approval Process and supplier qualification activities including familiarity with documentation requirements, process validation, and supplier readiness considerations; Demonstrated ability to manage supplier quality deliverables within project timelines and coordinate activities across cross functional teams; Basic understanding of cardiovascular device applications including general knowledge of heart anatomy; Experience supporting cross-functional and cross-regional teams in a matrixed org.
• Must haves - Required Qualifications: Baccalaureate degree AND 4+ years of relevant experience OR Master's degree with 2+ years relevant experience OR PhD with 0 years relevant experience

Qualifications

• Baccalaureate degree AND 4+ years of relevant experience OR Master's degree with 2+ years relevant experience OR PhD with 0 years relevant experience

Skills

• Engineering experience within the medical device industry, specifically disposable devices and/or capital equipment
• Familiarity with Production Part Approval Process and supplier qualification activities including documentation requirements, process validation, and supplier readiness considerations
• Demonstrated ability to manage supplier quality deliverables within project timelines and coordinate activities across cross functional teams
• General knowledge of heart anatomy
• Experience supporting cross-functional and cross-regional teams in a matrixed org.

Benefits

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, and Simple Steps (global well-being program).