The primary focus of this position is to provide sustaining engineering support for single-use fluid pathway assemblies used in Upstream and Downstream processing of biologics based on direct customer input. This position requires the application of design, investigation root cause analysis, product testing, data analysis and report writing to resolve customer complaints /product issues and implement existing product design improvements, all while working in a cross-functional team environment
• Interface directly with customers, suppliers and internal groups to resolve customer complaint investigations, drive root cause analysis and to implement design, process and supplier quality related solutions.
• Support the design, testing and release single-use consumable products; components, assemblies, packaging, tooling and fixtures. Analyze and validate custom designs per user requirements to meet performance, cost, compliance and manufacturability targets.
• Supporting product design to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD analyses) to lead design decisions.
• Create and maintain DHF; detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions.
• Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports.
• Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
• Release products through the ECR/ECO process.
• Support with CAPA activities and track Customer Complaint Investigation records in Trackwise System.
• Coordinate project priorities with team and Product Managers.
• Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
• Maintain a safe work area.
• Bachelor’s degree in either; BioEngineering, Mechanical Engineering, Plastics Engineering, Biochemistry, Biology, Chemistry, Chemical Engineering or Material Science.
• Minimum of 2 years relevant experience in Bioprocessing, Biopharmaceutical, Biotechnology, medical device development or a related field.
• Experience in plastic part design and GD&T per ASME Y14.5 standards.
• Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
• Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.
• Working knowledge of plastic materials, properties, Mfg. processes, and product assembly.
• Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
• Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.
• Experience with Microsoft tools; Word, Excel, Power Point, Project and Visio.
• Hands-on experience designing, prototyping and testing of components and assemblies.
• Good communication and influencing skills and ability to gain buy-in for initiatives.
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