Share Email Opening Apply Now Title Process Engineer  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description Scope of the Role The Extrusion Engineer plans, designs, and completes projects in extrusion manufacturing utilizing six sigma/lean/DMAIC or like methodologies. Creates and implements new products/processes, improves productivity, reduce customer complaints, and reduce costs. Drives improvements to reduce scrap, raise quality levels and optimize processes. Works with all the functions within the SPG internal team, as well as with outside vendors to coordinate implementation of new capital manufacturing equipment and processes to optimize production and increase capacity. Duties and Responsibilities Develop and implement new tooling, process improvements, new product process development, and cost/value improvement projects. Plan and coordinate the selection, procurement, installation, start-up, and qualification of new capital equipment, tooling, and fixtures for medical device manufacturing IQ/OQ. Perform cost improvement projects and quality improvement projects to support manufacturing goals that positively impact and reduce COGS. Implement and modify manufacturing task documents in coordination with process improvements and new equipment installations (change request). Develop and drive project plans by identifying tasks, resource requirements, time lines, and Cap Ex and expense budgets. Participate in the selection of Extrusion Equipment and tooling vendors. Develop equipment specifications from process and product specification. Ensure project completion on-time and within budget by tracking all project activities and providing management reports showing task status on requests. Provide equipment vendors with all documentation and sample components required to design, fabricate, troubleshoot, and accept equipment. Develop statistically valid equipment acceptance and installation protocols in conjunction with the manufacturing department personnel and Quality Assurance. Ensure all test methods specified in acceptance or installation protocols are properly defined and have acceptable measurement systems. Perform equipment acceptance testing and the results. Assist in installation and perform validation of new equipment. Determine the training for all personnel associated with the operation of the new equipment and provide those training materials. Comply with all local, state, federal, and SPG safety regulations, policies, and procedures (SPG safety absolutes). Comply with quality policies, procedures, and practices through consistent application of sound quality assurance principles outlined in the site quality manual and ISO13485:2016 requirements.   Position Requirements Key Skills and Attributes * BA or BS degree in Mechanical, Chemical, or Material Science preferred. * Hands on attitude with a focus on supporting the production floor. * Strong understanding of extrusion processing, plastic materials and ability to research materials. * Excellent interpersonal and communication skills; ability to work with employees at all levels. * Strong documentation skills with ISO 13485 knowledge preferred. * Minimum 3 years medical device manufacturing and/or extrusion/molding experience. * Computer proficient: Microsoft Office, CAD software, Minitab. * CNC fabrication and machining process experience beneficial but not required. * Understand customer requirements and application. * Six Sigma Greenbelt or equivalent certification beneficial but not required.   Location Precision Extrusion, Inc.   About the Organization Based in Alpharetta, Georgia with multiple plants across the United States, Mexico, Costa Rica, Ireland and Malaysia, Spectrum Plastics Group is a North American leader in the development and manufacture of specialty medical plastic products. Only Spectrum Plastics Group has the product breadth, expertise and global reach to deliver critical medical plastics at scale. We deliver operational excellence, innovative solutions and a high level of execution resulting in what our customers value most: precision, performance and repeatability. Spectrum Plastics Group offers a full range of custom design, engineering and fabrication services, as well as meets the requirements of ISO 9001, ISO 13485, FDA, operating multiple Class 7 & Class 8 clean rooms. When medical plastics are critical, the industry trusts us. Specialties: High performance extrusion Tight tolerance extrusion Extrusion Precision injection-molding Micro-molding Medical tubing PVC tubing Silicone Packaging Finished Devices/Assembly Contract manufacturing Clean room Thermoplastic tubing extrusion Medical device Medical plastics Medical components Microbore extrusion Bioabsorbables Catheters   This position is currently accepting applications. 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