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As a Pre-Market Supplier Quality Engineer, you will be responsible for partnering with Design, Reliability and Technical Sourcing to identify to develop, qualify and commercially release cost effective components and materials for use in the OUs products. In this area of new product development, the Supplier Quality Engineer will be required to drive multiple aspects of component and material development, qualification and validations with suppliers as a member of a cross-functional team.

Cardiac Ablation Solutions

CAS provides a broad suite of electrophysiology solutions intended to disrupt and lead the market in cardiac mapping and ablation technologies for arrhythmia management. These clinical and economical solutions will enable clinicians to treat patients with safer, faster and easier, and with more predictable procedure times and outcomes.

• 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

• Partner with Technical Sourcing to locate, evaluate, and approve new potential component/material suppliers that balance business, quality, and technical requirements. 

• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

• Lead issue resolution of complex problems as they relate to supplied components and materials. Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness.

• 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.

• 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.

• Perform process and component/material development work with suppliers to deliver highly capable components/materials. Applies principles of chemistry, physics and material behaviors in the development of supplier processes.

• Define component qualification strategy, partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Support project deliverables, supply risk reduction, yield improvement and cost reduction activities during development.

• Perform detailed analysis of component and material qualification data using Minitab and MS EXCEL software to ensure specification and capability requirements are met.

• Author component and material characterization, qualification and product acceptance documentation supporting supplier qualification activities.

• 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.

• Drive supplier requirements by collaborating with Development Engineering and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk. Partner with suppliers to ensure components are designed for reliability, manufacturability, and cost.

• This role will develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.

• Work to develop proper inspection tooling and test methods for new components to ensure supplier parts meet specification requirements. Perform statistical data analysis to determine tool and part/process performance. Evaluate Supplier capabilities for mechanical measurement via Gage R&R studies. Ensure appropriate acceptance activities are in place prior to commercialization.

• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

• Prepare and negotiate Quality Agreements with suppliers

• Develop technical solutions to complex problems using the corrective/preventative action process

• Lead or participate in supplier audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements

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 with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

Nice to Have

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

• Working knowledge of PPAP process

• ASQ CQE certification

• ASQ Lead auditor certification

• Manufacturing processes or R&D experience

• Firm understanding of inspection and manufacturing processes (laser micrometers, optical measurement systems, tool scopes, injection molding, thermoforming, metal forming/machining, etc.)

• Some level of Experience with qualifying with Contract Manufacturing.

• Demonstrated working knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation and non-conforming product controls

• PC skills, MS Office (Minitab, Word, Excel, PowerPoint and Project)

• Working advanced knowledge level of statistics and DOE execution

• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485

• Strong communication skills; both written and oral to internal and external customers including strong interpersonal skills to enable working across multiple functions such as Design Engineering, Sourcing, Commodity Management and Quality to resolve issues

• Strong problem-solving skills (DMAIC, Kepner Trego, Fishbone, etc.) – Green Belt DRM or 6S

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.