Location(s): United States; Massachusetts; Marlborough
About Us: 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: The person will be responsible for leading process development, technology transfer, and supporting production scale-up for new product introductions (NPI) for our R&D team at GE Life Sciences in Marlborough and Westborough, MA. Current processes include our hollow-fiber filter (membrane) manufacturing, and our assembly lines for single-use fluid pathway consumable products, all of which are used with bioreactors and related bioprocess manufacturing equipment for the pharmaceutical industry.
Essential Responsibilities: • Lead the selection, capital acquisition, and acceptance testing of equipment based on analysis of specifications, risks, reliability and quality/regulatory requirements. • Work hands-on to install, modify, and de-bug manufacturing equipment, applying analytical knowledge and mechanical aptitude. • Characterize the impact of equipment process variables on design outputs. • Create detailed part and assembly drawings and associated Bill-of-Materials. • Generate, review and update the technical content of drawings, engineering specifications, protocols, reports, and other documents associated with the engineering process, and lead/participate in formal engineering design reviews. • Release products through the ECR/ECO process. • Complete PFMEA, Control Plan, and support SOP generation associated with product transfers and launches. • Generate, execute and analyze DOE, characterization and MSA studies for new products and new processes. • Aid in design of large and small equipment to meet their intended use. Ensure performance of engineering analyses (e.g., free-body diagrams, stress analyses) to aid in making design decisions. • Evaluate the quality, manufacturing feasibility, resource requirements and long-term performance of planned additions to the product line and provide feedback to the appropriate teams. • Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers. • Participate in global cross-functional teams, working effectively in a highly matrixed team environment to advance programs. • Ensure adherence to GMP and EHS safety procedures.
Qualifications/Requirements: • Bachelor’s degree in Engineering with a minimum of 5 years of relevant operations experience in mechanical engineering, Biotechnology or a related medical device/life science field OR High School Diploma with a minimum of 7 years of relevant operations experience in mechanical engineering, Biotechnology or a related medical device/life science field • Strong mechanical aptitude, knowledge of automation and PLCs, previous experience designing and executing DOEs and equipment qualifications, thorough understanding of electrical/mechanical and pneumatic systems. • Excellent verbal and written communication skills to technically and professionally describe test scenarios, deviations, non-compliances and risks.
Desired Characteristics: • Experience in Medical Device (ISO13485) and Pharmaceutical GMP environments. • Previous experience with various forms of polymer welding; traditional heat sealing (continuous & impulse) friction welding, ultrasonic and inductive would be a plus.
Locations: United States; Massachusetts; Marlborough
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