HireDiversity

Rochester, NY, US

SENIOR PLASTICS ENGINEER-5971121204

Description

Global Supply Chain, Medical Devices and Diagnostics (MD&D) is recruiting for a Senior Plastics Engineer for External Operations (level 25). 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 MD&D 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 External Operations/Source the Senior Plastics Engineer will function under the oversight of a manager or more senior technical leader as a project manager 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 NC's; working with external suppliers to validate process changes and replacement of materials or tooling; initiating, leading and 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 shall have experience in statistical tools such as DOE design/analysis, Gage R&R layout and analysis, as well process capability knowledge, (Cp/Cpk/Ppk), including analysis and control charting of data. Efficiency in use of Mintab statistical software is preferred. Candidate will author validation protocols and reports required for the development and qualification of injection molding/manufacturing process e.g. IQ/OQ/PQ process. It is preferred that candidate have experience in the RFQ process and capital planning.
Candidate will actively participate in team activities to help insure total team success; take an active role in learning for self and others to further company objectives; complete assignments involving a specific phase of an engineering project and/or line support activity; coordinate technical and/or business issues with internal and external customers; apply comprehensive and diverse knowledge of engineering and business principles to a broad range of assignments; plan, conduct and direct engineering/business projects to completion; maintain 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 strongly preferred, although equivalent experience will be considered. A minimum of 5 years experience working in industry is required.

The processes primarily supported by this position will require a plastics engineering skill set. A broad-based knowledge of materials, commodity and engineering grade resins, knowledge of manufacturing processes such as injection molding, extrusion, and blow molding, and tooling and part design is preferred. Demonstrated ability to lead, under the proper oversight, elements of complex technical projects confidently is strongly preferred. The candidate shall have experience in statistical tools such as DOE design/analysis, Gage R&R layout and analysis, as well process capability knowledge, (Cp/Cpk/Ppk), including analysis and control charting of data. Efficiency in use of Mintab statistical software is preferred. Candidate will author validation protocols and reports required for the development and qualification of injection molding/manufacturing process e.g. IQ/OQ/PQ process. It is preferred that candidate have experience in the RFQ process and capital planning Experience in an FDA regulated and/or GMP environment is preferred.

This position requires someone with very strong communication and influencing skills as interaction with multiple functions and various suppliers is required. Working in a Cross Functional Team environment is also required for this role. 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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Primary Location:North America-United States-New York-Rochester
Organization: OCD Inc. (6118)
Relocation: Eligible
No
Travel:Yes, 50% of the time