Katalyst CRO
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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)
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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