Mechanical Engineer, Life Cycle Engineering
Westborough (Worcester County) Design / Civil engineering / Industrial engineering
Job description
3083350
City
Westborough
Career Level
Experienced
Relocation Assistance
No
Business
GE Healthcare
Business Segment
Healthcare Life Sciences
Function
Engineering/Technology
Country/Territory
United States
U.S. State, China or Canada Provinces
Massachusetts
Postal Code
01581-1019
Role Summary/Purpose
The focus of the Life Cycle Engineering group is to provide sustaining engineering support for single-use fluid pathway assemblies for upstream and downstream processing of biologics based on direct customer input. This position requires the application of design, engineering, root cause analysis investigation, product testing, data analysis and report writing to resolve and improve product design, process and quality issues. This position is based in the R&D Bio-Process function.
Essential Responsibilities
Mechanical Engineering:
• Design of single-use products; components, assemblies, packaging, tooling and fixtures. Analyze and validate tolerances, performance, cost and manufacturability.
• Supports designing products to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD analyses) to aid in making design decisions.
• Create detail and assembly drawings and associated Bill-of-Materials.
• Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports.
• Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
Leadership:
• Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
• Interface with customers and cross-functional groups for complaint investigations, drive root cause analysis and implement quality and design related improvements.
• Release products through the ECR/ECO process.
• Maintain safe work area.
Qualifications/Requirements
• Bachelor’s degree in either Mechanical Engineering, Plastics or Biomedical Engineering.
• 2+ years of relevant experience in Mechanical engineering, Biological Sciences, Biotechnology, medical device development or a related field.
• Proficient in CAD solid modeling tools; SolidWorks, Pro/Engineer or CREO.
• Experience in plastic part design and GD&T per ASME Y14.5 standards.
• Working experience with plastics and relevant material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
• Basic understanding of materials, properties, Mfg. processes, and product assembly.
• Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
• Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.
• Familiarity with relevant regulatory and QA guidelines governing implementation and use of disposable materials and components.
• Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.
• Hands-on experience designing, prototyping and testing of components and assemblies
Desired Characteristics
• Master’s degree in either; Mechanical Engineering, Plastics or Biomedical Engineering.
• Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
• Ability to be responsive to customer’s requests.
• Experience project planning and scheduling using MS Project.
• Experience in CAE analysis tools; FEA, CFD and MoldFlow.
• Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.
• Experience in leading projects/activities to meet customer requirements.
• Six Sigma Certification (Green Belt, Black Belt).
• Application of risk management methodologies to aid in meeting commitments
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.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual 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 Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen.