Must possess at least five (5) years’ experience with each of the following: FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, and GMP; PPAP and IQ/OQ/PQ; Minitab, TMV, Capability (Ppk / Tolerance Intervals), and SPC; Control Plan, Process Flow Map, and PFMEA; Creation and approval of V&V protocols, reports for top-level assembly and sub-assembly test acceptance criteria, sample sizes based on component/feature criticality, and sampling plans; AGILE, SAP, and ERP systems; Executing First Article Inspection activities and summation of results; and Updating BOM structure within QMS. Masters’ Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a manufacturing or design engineer for medical devices, or, Bachelors’ Degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and seven (7) years of experience as a manufacturing or design engineer for medical devices.