We are looking for a Project Engineer on behalf of one of the largest Healthcare company in Westborough, MA. Product care engineer should have experience in a sustaining organization and have experience working on complaints for existing product that is on the market already.
The Project Engineer position is located in the Westborough R&D Life Cycle & Custom Engineering group within the Biotechnology business area. The primary focus of this position is to provide sustaining engineering support for single-use fluid pathway assemblies used in Downstream processing of biologics based on direct customer input. This position requires root cause investigation, product testing, data analysis and report writing, solution identification, and change implementation to resolve customer complaints and product issues, 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.
- Attends weekly Product Care meetings to learn about product issues.
- Provides ownership of product care issues.
- Create and maintain detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions.
- 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.
- Bachelor’s degree in either Mechanical Engineering, Plastics Engineering, or BioEngineering.
- Minimum of 2 years relevant experience in Bioprocessing, Biopharmaceutical, Biotechnology, medical device development or a related field.
- Experience in CAD solid modeling tools; preferably SolidWorks and/or CREO.
- Experience in plastic part design and GD&T per ASME Y14.5 standards.
- Working knowledge of plastic material characteristics and manufacturing processes, 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.
- Knowledge of sterilization methods for pharmaceutical equipment and/or medical devices.
- Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
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