Provide technical engineering expertise and serve as the technical liaison between Medtronic design requirements and suppliers' technical capability to support business objectives; facilitate Lean-Sigma continuous improvement with suppliers, support and implementation; identify risks associated with low margins between supplier processes and design requirements; understand and conform with medical device industry standards and regulatory requirements to include Food and Drug Administration (FDA) regulations, ISO 13485, ISO 14971, 21 CFR
Part 820, IEC 60601, Corrective Action & Preventive Action (CAPA), and GMP (Good Manufacturing Practices); execute lean transformation projects, product transfers, cost savings and material replacement projects with suppliers; coordinate and drive continuous improvement activities including process characterizations and optimization using methodologies including Design of Experiments (DOE), Time studies, value analysis and value engineering (VAVE), DRM (Design, Reliability and Manufacturability), and Lean Six Sigma; facilitate selection of new
suppliers ensuring Medtronic design requirements are met; coordinate root cause investigations of product or process non-conformances using six sigma methodology; establish process flows, coordinate process validations using Installation Qualification, Operational Qualification and Performance Qualification (IQ/OQ/PQ) protocols; oversee statistical analysis by using techniques including Gage R and R, ANOVA, variables data distribution, sample size calculation, statistical process control, and Capability and Normality Assessments; oversee and coordinate Critical Feature Identification (CFI), Critical to Quality (CTQ) determination, Process Failure Mode and Effect Analysis (PFMEA), and Design Failure Mode and Effect Analysis (DFMEA) activities; and coordinate inspection methods including variables and attribute.
Position works a hybrid model and will be onsite in Lafayette, CO -- 3 days per week. Relocation assistance is not available for this position.
Position requires a Bachelors' Degree in Electrical, Mechanical or Biomedical Engineering or related engineering field and four (4) years as a supplier, electrical or quality engineer or related occupation in supplier quality engineering for medical devices. Must possess at least four (4) years' experience with each of the following: FDA regulations, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, CAPA, and GMP; Lean transformation projects, product transfers, cost savings and material replacement projects; Process characterizations and optimization using methodologies including DOE, Time studies, VAVE, and Lean Six Sigma; Identifying root cause of product or process non-conformances; Establishing process flows and conducting process validations using IQ/OQ/PQ; Gage R &R, ANOVA, variables data distribution, sample size calculation, statistical process control, and Normality Assessments; CFI, PFMEA, DFMEA, and CTQ; and Coordinating inspection methods including variables and attribute.