Manufacturing Engineer � Medical Devices

SummarySeeking a Manufacturing Engineer to support medical device production, improve processes, and ensure compliance with FDA and ISO standards.Roles & ResponsibilitiesOptimize and troubleshoot manufacturing processes. Lead validations (IQ/OQ/PQ) and maintain compliant documentation. Support CAPA, nonconformances, and root-cause investigations. Drive Lean/5S/Six Sigma projects to improve yield, cost, and efficiency. Partner with Quality, R&D, and Operations on NPI and process improvements. Education & Experience:Bachelor's in Mechanical/Biomedical/Manufacturing Engineering. 2-5+ years' experience in medical device or regulated manufacturing. Strong understanding of FDA 21 CFR 820, ISO 13485, validation & DFM. Hands-on troubleshooting and process optimization experience.