Senior Supplier Quality Engineer
About The Position
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. The ideal candidate will have experience managing supplier & component qualification during NPD programs, resolving quality-related issues through effective collaboration and communication, and evaluating the impact of Supplier changes on existing qualifications and validations to support smooth program execution. 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.
Requirements
- Baccalaureate degree AND 4+ years of relevant experience OR Master's degree with 2+ years relevant experience OR PhD with 0 years relevant experience
- 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 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. developing collaborative relationships
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 communicates 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
- 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
- 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)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
