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Mechanical Project Engineer

Westborough, MA
Essential Responsibilities 
• 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. 

• Master’s degree in either; BioEngineering, Mechanical Engineering, Plastics Engineering, Biochemistry, Biology, Chemistry, Chemical Engineering or Material Science. 
• Hands-on experience with BioProcessing equipment and application methods. 
• Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO. 
• Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules. 
• Experience in CAE analysis tools; FEA, CFD and MoldFlow. 
• Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams. 
• Experience in leading projects/activities to meet customer requirements. 
• Familiarity with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993. 
• Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS. 
• Experience working in an Agile work environment. 
• Application of Risk Management methodologies to aid in meeting commitments 
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