Manufacturing Engineer
On-site · Mount Sterling, Ohio, United States
Job Summary
Manufacturing Engineer focused on optimizing manufacturing processes for medical devices, with data-driven continuous improvement, sustaining engineering, root-cause analysis, and collaboration with vendors to ensure equipment and materials meet safety, quality, and customer requirements. Responsibilities include leading RCA, performing data analysis for process improvements, defining equipment specifications, ensuring ISO 13485 compliance, managing change controls (ECOs), maintaining QMS documentation, coordinating audits and CAPA investigations, and leveraging Lean/Six Sigma tools alongside SolidWorks in a manufacturing setting.
Required Qualifications
- Bachelor's degree in mechanical engineering (ABET-accredited)
- 3+ years of applied professional experience in sustaining engineering or process engineering
- Preferred medical device manufacturing experience, with understanding of ISO 13485 and ISO 14971
- Project management experience preferred
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