Product Test Engineer - Custom components, Bioprocess
Posted 7/26/2017 5:09:03 PM
Business Segment: Healthcare Life Sciences
Location(s): United States; Massachusetts; Westborough
About Us: 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
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: This position requires the application of design, engineering, drafting, product testing, data analysis, report writing and task self-management skills to aid in customizing multiple product lines, all while working in a cross-functional team environment.
Essential Responsibilities: • Design components, assemblies, packaging, tooling and fixtures; analyze and validate tolerances, performance, cost and manufacturability.
• Source components.
• Engineer products to meet their intended use. Ensure performance of engineering analyses (e.g., free-body diagrams, stress 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 a cross-functional team to resolve issues.
• Release products through the ECR/ECO process.
• Maintain safe work area.
Qualifications/Requirements: • Bachelor’s degree in Engineering
• 3-5 years of relevant experience in Biological Sciences, Chemistry, Chemical Engineering, Mechanical engineering, Biotechnology or a related field
• Strong 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, 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
• Demonstrated ability to create models with CAD software.
• Ability to write reports; communicate test analysis and results
• Familiarity with relevant regulatory and QA guidelines (Preferably, governing implementation and use of disposable materials and components).
• Hands on experience designing, prototyping and testing and implementing components and designs.
Desired Characteristics: • Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
• Ability to be responsive to customer’s requests.
• Flexibility required in a small business environment where multitasking and performing different tasks, including hands on work, is needed to get the job done
• Hands-on experience with Solid Works
• Efficient with MS Project and Visio
• Experience in leading projects/activities to meet customer requirements
• Use of DFSS in designing products
• Application of risk management methodologies to aid in meeting commitments
Locations: United States; Massachusetts; Westborough
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