Role Description In this exciting role as Supplier Quality Engineer II, you will be responsible for the management of our strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) at Medtronic, with accountability to support changes to existing supplied products and processes, as well as oversight of performance and improvement activities. While partnering with our CMs and OEMs, including sub-tier suppliers as required, this position is responsible for maintaining necessary controls and driving improvements relating to finished medical device/component quality in conjunction and within our suppliers’ quality systems. The individual is expected to be proficient in communication, project management, and troubleshooting complex medical devices involving mechanical, electrical, and software interactions. Hands-on experience with schematics, system diagnostics, and root cause analysis is required. Familiarity with medical device quality standards (ISO 13485, IEC 60601, IEC 62304) and structured problem-solving in a regulated environment is essential. Responsibilities may include the following and other duties may be assigned: - 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. - Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. - 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. - Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD. - Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products. - Defines Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods. Qualifications - Strong technical background in medical device mechanical assembly processes. - Experience with injection molded components, tooling considerations, and molding-related defect analysis. - Strong knowledge of metrology & measurement techniques; statistical analysis (Ppk/Cpk, standard deviation, etc.) in Minitab, measurement uncertainty, GD&T, Gauge Repeatability & Reproducibility. - Experience with sterile barrier packaging, package integrity considerations, and packaging-related validation support. - Hands-on experience with root cause analysis, nonconformance investigation, and structured problem-solving. - Familiarity with medical device quality systems and regulated product development/manufacturing environments, including ISO 13485. - Ability to work cross-functionally with design, manufacturing, quality, supplier, and packaging engineering teams. - Strong interpersonal, organizational and project management skills. - Demonstrated communication skills, both verbal and written. - Computer skills in MS Office and ERP systems desirable. - ASQ CQE, CQA and/or CSQP certification. - First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified. - Demonstrated track record of effectively influencing and negotiating with others and leading effective/successful change initiatives. Requirements - Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience. Benefits - Medtronic offers a competitive Salary and flexible Benefits Package. - A commitment to our employees lives at the core of our values. - Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. - This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).