Process Engineer

Job Description : PROCESS ENGINEER TUBING EXTRUSION BOSTON USA Bachelors degree required Minimum of 15 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience Multi-lumen extrusion Free form extrusion Vacuum forming extrusion Shrink tubing Intermittent / full A/B extrusion Braided catheter extrusion Extruded Coating Multilayer co-extrusion Bump tubing Familiar with processing Pebax, Nylon derivates, polyurethane, engineering polymers 5+ years of experience in an extrusion manufacturing environment, preferably in a medical device setting. Experience in process validations, statistics and SPC using Minitab software Extensive knowledge of plastic chemistry and properties Experience in transferring product from pilot to production Proficient in designing, acquiring, and implementing new equipment and processes Familiar with design controls, FDA regulation - ISO 13485, 21 CFR 820, and CGMP practices Relies heavily on experience and judgment to plan and accomplish goals Good working knowledge of GD&T Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/PD/PC/OQ/PQ/TMV) Design tooling to support new extruded products or process improvements Lead and support a team of Engineers and Technicians Initiate, direct, and support projects to implement innovative equipment processes, and methods that enhance efficiency, improve safety, and increase profitability Hands-on role which requiring on-site support and managing other employees Proven ability to take the lead role in extrusion engineering functions which includes validating and troubleshooting processes, identifying and implementing process improvements, managing projects, and expanding extrusion capabilities

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