Senior Manufacturing Engineer - Medical Devices - Dorado, PR

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field. 5-7+ years in manufacturing engineering, process engineering, validation engineering, or quality engineering within an FDA-regulated environment. Strong working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments. Electrical and mechanical engineering background applied to automated or semi-automated manufacturing systems. Experience with automation/controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation. Proficiency in DOE, FMEA/PFMEA, CAPA, root-cause investigation, statistical analysis, and process capability tools; experience with Minitab, JMP, or equivalent preferred. Experience with Lean Manufacturing, Six Sigma, Kaizen, value stream mapping, or other continuous improvement methodologies preferred. Experience supporting p...