General Electric Mechanical Engineer 1-Cell Therapy in Marlborough, Massachusetts
A Mechanical Engineer works with cross-functional teams to develop complex disposables for cell and gene therapy customers. Activities include (but not limited to) detailed mechanical, material design, analysis, testing and manufacturing transfer of sub-systems and components.
Develop robust designs for new, custom, or existing products that can be produced cost-effectively and according to established project timelines
Leverages knowledge in advanced aspects of technical/functional areas and applies technical theory and practical experience with input from relevant functional areas to solve complex problems
Works independently and possesses a level of functional expertise necessary to influence and execute technical and project delivery execution
Work collaboratively with manufacturing operations team to resolve production engineering, quality testing issues
Act as key R&D contact for resolution of post-launch product quality issues, change control
Interface directly with manufacturing teams to clarify questions on drawings and designs. Assist manufacturing team in troubleshooting production issues on standard and special products.
Collaborate with Quality and Product Management to establish appropriate critical to quality (CTQ) characteristics. 8. Prepare using 2D and 3D CAD software mechanical drawings, assembly models complete with calculated dimensions and tolerances. 10. Revise and alter detailed and layout drawings to conform to engineering changes. 11. Prepare engineering change requests, engineering change notices, bills of material, engineering specifications, and customer submittals. 12. Direct the construction and testing of prototype disposables and pilot products and conduct analysis of the test Qualifications/Requirements:
BS in Materials/Plastics/Mechanical Engineering and 5-7 years relevant work experience
Knowledge of bioprocessing/cell therapy disposable, materials with relevant experience to design, development, manufacturing of new products
Broad understanding of manufacturing technology, quality control, testing of disposables used in bioprocess/cell therapy application
Experience with various methods for root cause analysis to address product issues
Demonstrated experience in developing design verification/validation plan, test procedure and reports
Hands-on lab testing, product verification, validation experience
Work experience in medical device/life science or related regulated industry
Full-life cycle product development experienceQuality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required Desired Characteristics:
Master’s degree in Mechanical Engineering and 8-10 years relevant work experience
Demonstrated technical leadership capability in integration activities
Self-starter, energizing, results oriented, and able to multi-task
Excellent teamwork, coordination and communication skills
Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets
Product development experience in medical device, life science industry
Effective oral and written communication skills
Global project experience
DFSS or Green Belt/Black Belt Certification About Us: GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . 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. Locations: United States; Massachusetts; MarlboroughGE will only employ those who are legally authorized to work in the United States for this opening.