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Manufacturing Engineer Medical Devices
Job in
Cincinnati, Hamilton County, Ohio, 45201, USA
Listed on 2026-03-04
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-03-04
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Summary:
Seeking a Manufacturing Engineer to support medical device production, improve processes, and ensure compliance with FDA and ISO standards.
Roles & 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/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.
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