Location(s): United States; Massachusetts; Westborough
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Role Summary: This position is in the R&D Life Cycle Engineering group within the Bioprocess business. The focus of this group is to provide sustaining engineering support for single-use fluid pathway assemblies for upstream and downstream processing of biologics based on direct customer input. This position requires the application of design, engineering, root cause analysis investigation, product testing, data analysis and report writing to resolve and improve product design, process and quality issues.
Essential Responsibilities: • Design components, assemblies, packaging, tooling and fixtures; analyze and validate tolerances, performance, cost and manufacturability. Source components. • Engineer products to meet their intended use. Ensure performance of engineering analyses (FEA and CFD analyses) to aid in making design decisions. • Create detail and assembly drawings and associated Bill-of-Materials. • 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. Leadership: • Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers. • Interface with a cross-functional team to resolve issues. • Interface with customers for complaint investigations, drive root cause analysis and implement quality and design related improvements. • Release products through the ECR/ECO process. • Maintain safe work area.
Qualifications/Requirements: • Bachelor’s degree in Mechanical Engineering, Plastics Engineering, Bioengineering, Biomedical Engineering or a related field • Minimum of 5 years of relevant experience in a sterile, or medical device development or a related field • Proficient with CAD tools for plastic part design and GD&T per ASME Y14.5 standards • Basic understanding of 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 • Ability to write reports; communicate test analysis and results • Familiarity with relevant regulatory and QA guidelines governing implementation and use of disposable materials and components. • Hands on experience designing, prototyping and testing and implementing components and designs.
Desired Characteristics: • Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams. • Ability to be responsive to customer’s requests. • Strong understanding of bio-compatible materials for use of sterile single-use application in bio-processing or medical device applications. • Flexibility and ability to multitask and perform different tasks as needed to get the job done (including hands on work). • Demonstrated ability to create models in SolidWorks • Efficient with MS Project and Visio • Experience in FEA and CFD analysis CAE tools. • Experience in leading projects/activities to meet customer requirements • Use of DFSS in designing products • Application of risk management methodologies to aid in meeting commitments
Locations: United States; Massachusetts; Westborough
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