Katalyst CRO
Manufacturing Engineer – Medical Devices
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.
Seniority Level Associate
Employment Type Contract
Job Function Manufacturing
Industry Pharmaceutical Manufacturing
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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.
Seniority Level Associate
Employment Type Contract
Job Function Manufacturing
Industry Pharmaceutical Manufacturing
#J-18808-Ljbffr