Katalyst CRO is hiring: Manufacturing EngineerMedical Devices in Cincinnati

Join to apply for the Manufacturing Engineer Medical Devices role at Katalyst CRO . Summary Seeking a Manufacturing Engineer to support medical device production, improve processes, and ensure compliance with FDA and ISO standards. Optimize 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. Seniority level Mid‑Senior level Employment type Full‑time Job function Engineering and Information Technology Industries Biotechnology Research, Retail and Appliances, Electrical, and Electronics Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x. Manufacturing Engineer (Multiple Positions) (REF272939U) Harrison, OH $67,983.00-$123,445.00 (1 month ago) Manufacturing Process & Packaging Engineer - Cincinnati Plant Cincinnati, OH $93,700.00-$140,700.00 (2 weeks ago) Quality Manufacturing -Process Engineer Level III Hebron, KY $93,100.00-$139,100.00 (3 weeks ago) Aero Engineer for Industrial Machinery R&D Fairfield, OH $60,000.00-$70,000.00 (1 month ago) Manufacturing Engineer Medical Devices Fairfield, OH $60,000.00-$70,000.00 (1 month ago) Cincinnati Process Engineer, 2nd Shift Cincinnati, OH $128,600.00-$213,600.00 (19 hours ago) #J-18808-Ljbffr