Basic Qualifications: Master's degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and three (3) years of experience as a quality/validation engineer or related occupation in quality engineering for medical devices; or alternatively, Bachelor's degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a quality/validation engineer or related occupation in quality engineering for medical devices. Must possess at least three (3) years' experience with each of the following: Extrusion and assembly manufacturing; 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP; PHA, PFMEA, and ISO 14971; Non-Conformances and CAPA; DMAIC, RCA, 5Whys, Fishbone, and cause mapping; DOE and process development; Process validation including IQ/ OQ/ PQ; and Statistical analysis software including Minitab.