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Role Summary: This is a unique opportunity to play a leading and fundamental role in the shaping development of a breakthrough technology in the field of biotherapeutic manufacture.
Essential Responsibilities: Joining a highly motivated and dynamic team in Stevenage who have recently joined GE Healthcare through acquisition. Working as a technical contributor and leader in cross-functional teams to design, prototype and develop complex state-of-the-art single use purification technologies using nanofibres. Technically lead product development projects from concept through design transfer into manufacturing.
Lead projects with participants across multiple functional areas
Work with the device design, engineering, and R&D teams to set goals and targets
Work with program leadership to ensure that the project deliverables are consistent with the goals of larger programs or initiatives.
Develop robust designs for new, special, or existing products that can be produced economically and according to established project timelines.
Prepare 2D and 3D CAD mechanical drawings, detailed drawings and assembly models complete with calculated dimensions and tolerances
Leverage 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
Performs complex calculations, analyses, and testing to verify assumptions.
Manage outside resources contracted for concept/product development, prototype/pilot fabrication and testing of devices when applicable
Support mentoring of junior technical talent
Engaging in all phases of new product development, including concept, architecture, documentation, design, prototype, test, supplier interfaces, manufacturing introduction and service support
Collaborate with Product Management to develop product specifications and requirements to drive the product development process
Collaborate with Quality and Product Management to establish appropriate critical to quality (CTQ) characteristics
Collaborate with Quality and Purchasing to establish appropriate quality metrics and PPAP requirements and to select appropriate suppliers
Generate and document intellectual property (IP).
Work with other functions to ensure the device formats are suitable for use in bioprocessing from a regulatory, manufacturing, and materials perspective.
Qualifications/Requirements: • Experience as an engineer in product development with past experience designing and launching products • Experience in project leadership within a manufacturing, development or research environment • Experience of developing industrial purification or filtration technologies • Understanding of biopharmaceutical purification scale-up/scale-down principles • Demonstrated experience with new product introductions, DFMA, ISO and regulatory compliance processes for the medical device or industrial bioprocessing markets • Strong understanding of bio-compatible materials for use in single-use applications for bioprocessing or medical device applications • Substantial experience of working with plastics and designing plastic parts for fabrication/joining methods e.g. diffusion bonding, ultrasonic, friction welding • Ability to write reports communicate test results and analysis • Excellent proficiency in using a 3D CAD package (preferably SolidWorks) to design parts and assemblies • Experience in CFD and FEA
• Outstanding communication and inter-personal skills • A practical approach to problem solving • Effectively convey design ideas and intent to the rest of the team through sketches and/or CAD drawings. • Proven ability to manage and work within multidisciplinary teams
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
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