Manufacturing Engineer

3 days ago


Cincinnati, OH, United States Katalyst Healthcares and Life Sciences Full time
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.
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.


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