Manufacturing EngineerMedical Devices
Job in
Cincinnati, Hamilton County, Ohio, 45208, USA
Listed on 2025-12-27
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-27
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Medical Device Industry, Biomedical Engineer
Job Description & How to Apply Below
Manufacturing Engineer – Medical Devices
Location:
Cincinnati, OH
Salary: $70,000.00 – $85,000.00
SummarySeeking a Manufacturing Engineer to support medical device production, improve processes, and ensure compliance with FDA and ISO standards.
Key Responsibilities- 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.
- Bachelor's in Mechanical, Biomedical, or Manufacturing Engineering.
- 2–5+ years’ experience in medical device or regulated manufacturing.
- Strong understanding of FDA 21 CFR 820, ISO 13485, validation, and DFM.
- Hands‑on troubleshooting and process optimization experience.
Mid‑Senior level
Employment typeFull‑time
Job functionEngineering and Information Technology
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