Senior External Manufacturing Engineer Job in Rochester, New York US
Global Supply Chain, Medical Devices and Diagnostics (MDD) is recruiting for a Senior External Manufacturing Engineer for External Operations. This position will be based at Ortho-Clinical Diagnostics (OCD) in Rochester, New York.
Medical Devices Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MDD SC supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life. For more information please visit www.orthoclinical.com
Reporting to the Manager of Supplier Engineering, the Senior External Manufacturing Engineer is responsible for functioning as an integral member of a team in support of manufacturing operations performed by external manufacturers, providing technical services to insure quality, cost and performance objectives are met. Completing failure investigations for customer complaints, CAPA's and NCR's. Working with external suppliers to validate process changes and replacement of materials or tooling. Initiating/leading/supporting cost improvement projects and business continuity initiatives. Providing technical support to assist in establishing and maintaining GMP compliant processes. Performing engineering studies and analyses on existing manufacturing processes to improve process reliability, product quality and cost.
The candidate will use appropriate statistical techniques to develop validation protocols, complete process capability studies and process validation on both internal and supplier processes. Actively participating in other team activities to help insure total team success; taking an active role in learning for self and others to further company objectives; completing assignments involving a specific phase of an engineering project and / or line support activity. Coordinating technical and or business issues with internal and external customers. Applying comprehensive and diverse knowledge of engineering / business principles to a broad range of assignments. Planning, conducting and directing engineering / business projects to completion. Maintaining clear communication with internal and external business partners regarding expectations, satisfaction, or quality of results. Other responsibilities may be assigned; not all responsibilities listed may be assigned.
Qualifications
A minimum of a Bachelors of Science in engineering or a technical discipline is required. A minimum of 5 years of relevant experience is required. The processes primarily supported by this position will require a mechanical / industrial engineering skill set. A broad-based knowledge of materials (plastics, silicones, metals, etc.) and processes (welding, machining, stamping, gluing, injection molding, etc.) is preferred. Adequate experience with ability to lead complex technical projects confidently is strongly preferred. Experience in a regulated and/or GMP environment required. Experience in an FDA regulated environment is preferred. This position requires someone with very strong communication and influencing skills as interaction with multiple functions and various suppliers is required. Experience in process improvement efforts using Process Excellence, Six Sigma and Lean Tools preferred. Proficiency with Microsoft Office is required.
The position will be based in Rochester, NY and may require up to 50% domestic and international travel.
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