Engineering Manager
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.