Ecocareers · 1 month 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 partnering with various departments for process improvements.
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