Engineering Manager
Position Description:
Engineering Manager for Medtronic, Inc., Minneapolis, MN. Responsible for planning, directing and implementing all aspects of the company's design and development of new medical device products or software systems. Develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Provide Quality Assurance Engineering for front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, effectiveness and safety. Utilize Medical Device industry standards in accordance with 21CFR Part 820, Part 11, Part 210/211, GMP (Good Manufacturing Practices), ISO 13485, and EU MDR. Coordinate Risk activities including Failure Mode and Effect Analysis (FMEA), Risk Reports that complies with ISO 14971 and IEC 62366. Coordinate Test Method Validation (TMV), Design Validation and Verification (Design V&V), and Process Qualification. Partner with Manufacturing Engineering and Research & Development Engineering to assist in developing test methods, process characterizations, design reliability, and process capability. Utilize Installation Qualification, Operation Qualification and Performance Qualification (IQ/OQ/PQ). Create and approve Design History File (DHF) deliverables and Device Master Record (DMR). Manage Non-Conforming Material Process and provide investigation, containment, disposition activities and CAPA (Corrective and Preventative Actions). Conduct statistical analyses and working with policy stakeholders regarding risk-based sampling methodologies. Utilize Root Cause Analysis methodologies such as Fault tree analysis, Ishikawa diagrams, Cause mapping and 5-why methodology. Position opens to telecommuting from anywhere in the U.S. #LI-DNI
Basic Qualifications:
Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and two (2) years of experience as a quality engineer or related occupation for medical devices; or alternatively a Bachelors’ degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a quality engineer or related occupation for medical devices. Must possess a minimum of two (2) years of experience with each of the following: ISO 13485, 21CFR Part 820, Part 11, Part 210/211, and GMP; FMEA and Risk Reports that complies with ISO 4971 and IEC 62366; TMV, Design V&V, Process Validation, and Design reliability; IQ/OQ/PQ; Non-conformance Material Process and CAPA; Statistical methodologies; and Root Cause Analysis including Fault tree analysis, Ishikawa diagrams, Cause mapping or 5-why methodology.
