Role Summary:Join the GE Healthcare Life Sciences R&D Life Cycle Engineering group. Focus on engineering activities for custom applications of single-use fluid pathway assemblies for upstream and downstream processing of biologics based on direct customer input. Role requires the application of design, engineering, product testing, data analysis, report writing and task self-management skills to drive customization of multiple product lines, all while working in a cross-functional team environment.
Support design of custom single-use 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, tolerance stack analyses) to lead design decisions.
Create detail and assembly drawings, specifications 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.
Manage activity at external test facilities to complete verification activities.
Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
Release products through the ECR/ECO process.
Coordinate project priorities with team and Product Managers.
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 Mechanical Engineering, Plastics Engineering, BioEngineering.
Minimum 2 years of relevant experience in Mechanical engineering, Biological Sciences, Biotechnology, medical device development or a related field.
Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.
Experience in plastic part design and GD&T per ASME Y14.5 standards.
Knowledge of plastics and relevant 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.
Knowledge 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, 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.
Strong communication and influencing skills and ability to gain buy-in for initiatives.
Desired Characteristics: Master's degree in either; Mechanical 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.
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.
Leverages historical test data and applies engineering judgement to rationalize verification testing where appropriate.
Experience with sterilization adoptions.
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
About Us: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.Additional Locations:United States;Connecticut, Massachusetts, New Hampshire, Rhode Island;Westborough, Marlborough, Framingham, Hartford, Nashua, Providence;