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 Systems Design Engineer will focus on complex product design, intellectual property development, problem-solving, risk reduction, system verification planning/testing and documentation for GE Life Sciences bioprocess equipment and single-use consumables for the pharmaceutical industry. He/she is responsible for integrating all subsystems for successful system development.
Essential Responsibilities: • Develop new product designs, integrate subsystems, troubleshoot errors, evaluate prototypes and verify feasibility for bioprocessing products such as in the Xcellerex, WAVE, and ReadyToProcess product lines. • Engage in all phases of product development including concept, design, feasibility, development, V&V, supplier interfaces, manufacturing introduction and service support. • Lead and support technical scope definition, user experience (UX), system architecture, intellectual property development, risk retirement & feasibility prove-out, quality & reliability goals, system design & requirements, requirements traceability & design review process, adherence to design controls, compliance process & program documentation, system verification & validation. • Apply creativity to resolve problems and develop solutions when presented with conflicting requirements, business demands and technical risks/issues. • Address implementation complexity, risks, manufacturability, serviceability and quality. • Design parts in 3D CAD modeling software (SolidWorks, Pro-E/Creo), create mechanical drawings, wiring diagrams, and schematics. • Generate and document intellectual property (IP). • Establish product critical to quality (CTQ) characteristics, specifications and requirements with cross-functional department input and VOC information. • Develop, document, and execute verification tests to evaluate performance metrics. • Create, fabricate, setup, and debug verification test apparatus, fixtures and related equipment. • Prepare engineering change requests, engineering change notices, bills of material, engineering specifications, and customer submittals. • Collaborate closely and effectively with cross-functional departments worldwide – Marketing, Quality, Regulatory and Manufacturing to drive projects to completion.
Qualifications/Requirements: • BS Degree in Mechanical, Electrical, Biomedical Engineering or related degree. • Minimum of 6 years’ relevant experience in product development sustaining engineering or equivalent, with experience designing and launching products. • Knowledgeable with ISO, FDA and other regulatory standards and requirements. • Experience with design for usability and electrical safety compliance. • Knowledge in statistics analysis, DOE, root cause analysis, risk management, and FMEA. • Proficient with 3D CAD modeling software. • Experience developing design verification methods and test method validations. • Effective communication skills and ability to work cooperatively within a global, multidisciplinary team, including written and oral communication. • Experienced working in ISO9000 or 13485 environments, with regulatory compliance processes and creation of design history files.
Desired Characteristics: • Knowledge of FEA and CFD analysis. • Master’s Degree in Engineering (electrical, mechanical, plastics or similar field)
Locations: United States; Massachusetts; Marlborough
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