As Senior Project Engineer in our R&D Life Cycle Engineering group, focus on leading sustaining engineering activities for single-use fluid pathway assemblies used in Upstream and Downstream processing of biologics based on direct customer input. Requires the application of design, root cause analysis investigation, product testing, data analysis and report writing to resolve and improve product design, process and quality 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 to identify and implement design, process and supplier quality related solutions.
Lead 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.
Leading 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.
Lead 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.
Candidates should note that this role will be in scope for the proposed transition of GE Biopharma to Danaher and will transfer to Danaher at close of this transaction.
Bachelor's degree in either; Mechanical Engineering, Chemical Engineering, Plastics Engineering or BioEngineering.
Minimum of 8 years relevant experience in either; Bioprocessing, Pharma, or related Biotechnology.
Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.
Strong 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.
Strong understanding of material properties, Manufacturing 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.
Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.
Hands-on experience designing, prototyping and testing of components and assemblies.
Excellent communication and influencing skills and ability to gain buy-in for initiatives.
Master's degree in either; Mechanical Engineering, Chemical Engineering, Plastics Engineering or BioEngineering.
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 Design For Six Sigma.
Experience working in an Agile work environment.
Application of Risk Management methodologies to aid in meeting commitments
GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
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