Title Project Engineer, Life Cycle Engineering

Job Number 3053745

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 This Project Engineer position is located in the Westborough R&D Life Cycle Engineering group within the Biotechnology business area in GE Healthcare Life Sciences.

Essential Responsibilities 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.

Essential Responsibilities:

Project Engineer, LCE R&D Group:

• Interface directly with customers and internal groups to resolve customer complaint investigations, drive root cause analysis and implement quality and design related improvements.
• Run small project with cross-functional teams, create WBS and Gannt chart schedules.
• Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports.
• Assists in designing products to meet their intended use. Ensure performance of engineering analyses to aid in making design decisions.
• Contributes in the design of plastic components, assemblies, packaging, tooling and fixtures; analyze and validate tolerances, performance, cost and manufacturability.
• Creates and maintains; detail and assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
• Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
• Release products through the ECR/ECO process.
• Maintain safe work area.

Qualifications/Requirements chelor's degree in either; Mechanical Engineering, Plastics Engineering, Bioengineering, Material Science, Microbiology or Chemistry.

• 3 to 5 years of relevant experience in either; Bio-Processing, Biological Sciences, Biotechnology, medical device development or a related field.
• Ability to be responsive to customer's requests; lead customer complaint investigations, complete root cause analysis and implement risk management methodologies.
• Knowledge of plastics and relevant material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
• Basic understanding of materials, properties, manufacturing 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.
• Ability to write reports; communicate test analysis and results.
• Familiarity with relevant regulatory (FDA, ISO) and QA guidelines governing implementation and use of disposable materials and components.
• Hands-on experience with designing, prototyping and testing and implementing new components and designs.
• Strong communication and writing skills for working with global manufacturing, marketing, and development teams.
• Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.

Desired Characteristics ster's Degree in either; Engineering, Material Science, Microbiology or Chemistry.

• Project Management Professional (PMI/PMP) Certification.
• Proficient in solid modeling CAD tools; either SolidWorks or Pro/Engineer.
• Familiar with GD&T per ASME Y14.5 standards.
• Experience in FEA, CFD and MoldFlow analysis CAE tools.
• 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).

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 an . 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.