Offers “General Electric”

Expires soon General Electric

Project Engineer, Life Cycle Engineering

  • Internship
  • Westborough (Worcester)

Job description



3404887
Additional Cities

Westborough
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare BioPharma
Function

Engineering/Technology
Country/Territory

United States
Additional States/Provinces

Massachusetts
Postal Code

01581-1019
Role Summary/Purpose

The primary focus of this position is to provide sustaining engineering support for single-use fluid pathway assemblies used in Upstream and Downstream processing of biologics based on direct customer input. This position requires the application of design, investigation root cause analysis, product testing, data analysis and report writing to resolve customer complaints /product issues and implement existing product design improvements, all while working in a cross-functional team environment
Essential Responsibilities

• Interface directly with customers, suppliers and internal groups to resolve customer complaint investigations, drive root cause analysis and to implement design, process and supplier quality related solutions.
• Support the design, testing and release single-use consumable products; components, assemblies, packaging, tooling and fixtures. Analyze and validate custom designs per user requirements to meet performance, cost, compliance and manufacturability targets.
• Supporting product design to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD analyses) to lead design decisions.
• Create and maintain DHF; detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions.
• 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.
• Release products through the ECR/ECO process.
• Support with CAPA activities and track Customer Complaint Investigation records in Trackwise System.
• Coordinate project priorities with team and Product Managers.
• Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
• Maintain a safe work area.
Qualifications/Requirements

• Bachelor’s degree in either; BioEngineering, Mechanical Engineering, Plastics Engineering, Biochemistry, Biology, Chemistry, Chemical Engineering or Material Science.
• Minimum of 2 years relevant experience in Bioprocessing, Biopharmaceutical, Biotechnology, medical device development or a related field.
• Experience in plastic part design and GD&T per ASME Y14.5 standards.
• Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
• Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.
• Working knowledge of plastic 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.
• Experience with Microsoft tools; Word, Excel, Power Point, Project and Visio.
• Hands-on experience designing, prototyping and testing of components and assemblies.
• Good communication and influencing skills and ability to gain buy-in for initiatives.
Desired Characteristics

• Master’s degree in either; BioEngineering, Mechanical Engineering, Plastics Engineering, Biochemistry, Biology, Chemistry, Chemical Engineering or Material Science.
• Hands-on experience with BioProcessing equipment and application methods.
• Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.
• Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.
• Experience in CAE analysis tools; FEA, CFD and MoldFlow.
• Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
• Experience in leading projects/activities to meet customer requirements.
• Familiarity with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.
• Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
• Experience working in an Agile work environment.
• 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.
Healthcare Life Sciences There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.
Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.

Learn More About GE Healthcare – Life Sciences

Learn More About Careers at GE Healthcare – Life Sciences

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.

Locations: United States; Massachusetts, Boston, Westborough, Marlborough, Framingham,

GE will only employ those who are legally authorized to work in the United States for this opening.

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, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any 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 (as applicable).
Primary Country

United States
Primary State/Province

Massachusetts
Primary City

Westborough

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