Ecocareers · 2 months ago
Manufacturing Engineer – Medical Devices
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
2+ years expConfidential company 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/5S/Six Sigma projects.
Staffing & Recruiting
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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase