Katalyst CRO · 1 month ago
Manufacturing Engineer – Medical Devices
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
2+ years expKatalyst CRO is seeking a Manufacturing Engineer to support medical device production, improve processes, and ensure compliance with FDA and ISO standards. The role involves optimizing manufacturing processes, leading validations, and driving Lean projects to enhance efficiency and yield.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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