Location(s): United States; Massachusetts; Marlborough
About Us: 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. Learn More About GE Healthcare – Life Sciences
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.
Role Summary: Mechanical design engineer and technical contributor in cross-functional project teams to mechanically design/redesign, troubleshoot, and develop complex, single-use, consumable, bioprocess products such as in the Xcellerex, WAVE, and Ready To Process product lines. Design leader on projects from concept through design transfer into manufacturing.
Essential Responsibilities: • Design, prototype, develop and document new product offerings, primarily consumable, single-use bioprocessing 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. • Specify materials, and establish acceptable performance standards. Address implementation complexity, risks, manufacturability, serviceability and quality. • Engage in all phases of product development, including concept, architecture, documentation, design, prototype, test, supplier interfaces, manufacturing introduction and service support. • Adhere to design control requirements including the creation of CAD models, assemblies, drawings, detailed specifications, design verification and validation plans, protocols and reports. • Establish product critical to quality (CTQ) characteristics, specifications and requirements with cross-functional department input and VOC information. • Collaborate with Quality and Purchasing to establish appropriate quality metrics and PPAP requirements, and select appropriate suppliers. • 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.
Qualifications/Requirements: • BS Degree in Mechanical Engineering or related degree • Demonstrated experience in plastic part design for injection molding • Proficient with 3D modeling software (e.g. Solidworks, Pro-E, Creo) • Knowledge of FEA and CFD analysis • Minimum 8 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
Desired Characteristics: • Strong written and verbal communication skills • Experience working in stage gate development process and global project teams • Experienced working in ISO9000 or 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)
Locations: United States; Massachusetts; Marlborough
We are in the process of transitioning to an improved job application system and in the interim we are operating with two systems. Have your Job ID ready (from the email you received when you applied) to log in and check your application status.
Click the appropriate button. If you don't know your job ID, you can still check your status: use both buttons.