Role Summary:The Lead Development Engineering will be an integral project engineer and technical contributor in cross-functional project teams to mechanically design, test, verify and validate complex, single-use, consumable & hardware, bioprocess products such as in the Xcellerex, WAVE, and Ready To Process product lines. Responsible for activities from concept through design transfer into manufacturing.
Engage in all phases of product development, including concept, architecture, documentation, design, prototype, test, supplier interfaces, manufacturing introduction and service support.
Design, prototype, develop and document new product offerings, single-use bioprocessing equipment and consumable products such as in the Xcellerex, WAVE, and ReadyToProcess product lines.
Create 3D CAD part and assembly models, and detailed drawings complete with calculated dimensions and geometric (GD&T) tolerances.
Procure materials, fabricate functional sub-systems for proof-of-concept evaluations, and confirm feasibility of design.
Establish performance and functional specifications and requirements, identify critical to quality (CTQ) characteristics with cross-functional department input and VOC information, and ensure all are verifiable.
Specify materials and establish acceptable performance standards. Address implementation complexity, risks, manufacturability, serviceability and quality.
Adhere to design control requirements including the creation of CAD models, assemblies, drawings, detailed specifications, design verification and validation plans, protocols and reports.
Collaborate closely and effectively with cross-functional departments worldwide Marketing, Quality, Regulatory and Manufacturing to drive projects to completion.
Identify, collaborate and manage outside suppliers on material selection, tool design, manufacturing technologies and specifications for components, subassemblies, finished assemblies.
Generate and document intellectual property (IP).
Performs complex calculations, analyses, and testing to verify assumptions.
Prepare engineering change requests, engineering change notices, bills of material, engineering specifications, and customer submittals.
Maintain and develop competence required for the job
BS Degree in Mechanical Engineering or related degree
Proficient with 3D modeling software (e.g. Pro-E, Creo)
Knowledge of FEA and CFD analysis
Minimum 5 years' experience as an engineer in product development or sustaining engineering, with experience designing and launching products
Familiarity with ISO, FDA and other regulatory standards
Knowledgeable of a variety of manufacturing methods, including injection molding, extrusion, machining, and assembly processes
Knowledge in statistics, risk management and FMEA tools
Strong written and verbal communication skills
Desired Characteristics: Demonstrated experience in plastic part design for injection molding
Competent with FEA and CFD analysis
Experience working in stage gate development process and global project teams
Cell culture or bioprocessing knowledge and experience
Experienced working in ISO 13485 environment, with regulatory compliance processes and creation of design history files
Self-starter, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
DFSS or Green Belt/Black Belt Certification
Master's Degree in Engineering (Mechanical, plastics or similar field)
About Us:GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Healthcare Life Sciences 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.
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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, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.Additional Locations:United States;Massachusetts;Marlborough;