Role: Manufacturing & Quality Engineer
Location: Cincinnati, Ohio
Position Overview
We are seeking an experienced Manufacturing & Quality Engineer to support process improvements, new product transfers, and equipment validation within a medical device manufacturing environment. The ideal candidate will bring strong technical expertise in quality systems, machining, and lean methodologies while ensuring compliance with FDA/ISO regulations.
Key Responsibilities
- Drive process improvements using Statistical Analysis, Lean, Six Sigma, and GMP principles.
- Support new product introductions and design change transfers to the production floor.
- Implement machining and safety enhancements to reduce scrap and improve performance.
- Develop and maintain technical protocols, process documentation, visual instructions, and training materials.
- Lead equipment specification, procurement, and validation activities.
- Ensure compliance with FDA/ISO standards, design control requirements, and reprocessing guidelines.
Qualifications
- Bachelor's degree in Engineering with 4+ years of medical device manufacturing experience.
- Strong knowledge of quality systems, GD&T, machining processes, and orthopedic products.
- Hands-on experience with engineering change orders, structured troubleshooting, test lab development, and Lean methodologies.
- Preferred background in extrusion, polymers, micro tubing, and process validation.