Contract Manufacturing Program Manager at Medtronic in Danvers, Massachusetts

Job Description:

Position Description:
Contract Manufacturing Program Manager for Medtronic, Inc. located in Danvers, MA. Collaborate with Medtronic Contract Manufacturing Suppliers to develop and drive the strategy of the supply management organization in alignment with the Global Supply Chain Function. Responsible for the Contract Manufacturers' Product Portfolio quality, service and cost performance by coordinating the business & strategic initiatives with Contract Manufacturing Suppliers, Operations from New Product Development to Transfer & Implementation & throughout the complete product lifecycle. Leverage Installation qualification (IQ), operational qualification (OQ) and product qualification (PQ). Responsible for coordination of manufacturability and risk methodologies including PFMEA (process failure mode effect analysis) and DFMEA (Design failure mode effect analysis), and FTA (Fault tree analysis). Utilize various statistical analysis tools to include Design of experiments (DOE), Analysis of variance (ANOVA), Geometric dimensioning and tolerancing (GD&T), and Gage repeatability and reproducibility (GR&R). Navigate the complexities of various industry and government regulations to include FDA 21 CFR Part 820, ISO 9001, ISO 13485, ISO 14971, IEC 60601 & 62366 standards. Coordinate for DRM (Design for Reliability and Manufacturability) engineering frameworks. Leverage various Lean Sigma and Six Sigma methodologies, conduct capacity planning and develop manufacturing project schedule to achieve quality, delivery, and cost performance expectations. Coordinate product investigations utilizing RCA (Root cause analysis) and CAPA (Corrective and Preventive actions), and Supplier Changes. *This position is open to telecommuting from anywhere in the U.S.

Basic Qualifications:
Master's degree in Chemical, Biomedical, Materials, Industrial or Mechanical Engineering and three (3) years of experience in component engineering; or alternatively, Bachelor's degree in Chemical, Biomedical, Materials, Industrial or Mechanical Engineering and five (5) years of experience in component engineering. Must possess three (3) years of experience with each of the following: IQ/OQ/PQ; PFMEA, DFMEA, and FTA; statistical analysis to include DOE, ANOVA, GD&T, and Gage R&R; FDA 21 CFR Part 820, ISO 9001, ISO 13485, ISO 14971, IEC 60601 & IEC 62366; Lean Sigma and Six Sigma methodologies; DRM; Capacity Planning; and RCA and CAPA.