Extrusion Technical Development Specialist Position Available In Wake, North Carolina

Extrusion Technical Development Specialist 3.1 3.1 out of 5 stars 1041 Classic Rd, Apex, NC 27539 Who we are: Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle.

About the role:

The Technical Development Subject Matter Expert (SME) is responsible for taking customers’ input and translating it into working prototypes on various extrusion machines, such as Flat die extrusion, Layflat extrusion, and Lamination. This role ensures the extrusion lines are set up appropriately and run efficiently while meeting customer expectations with respect to Quality and timelines. This role is a key contributor to the Solesis organization in achieving company metrics: on-time delivery, revenue, quality, and safety. 1st shift Monday-Friday 8:00 am-5:00 pm What you will do: Lead and perform machine setups, production, and development runs to hit desired product specifications without direct oversight from product development or operations leadership. Troubleshoot and complete general maintenance of extrusion equipment. Ability to assemble and disassemble extruders for cleaning, and/or job changes that require different tooling with a new setup. Coordinates the training process on equipment, internal procedures, SOPs, and work instructions and ensures the standards are followed. Follow all Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) when completing daily tasks. Create and use production travelers and other documentation to identify and verify raw material accuracy prior to starting manufacturing and development runs. Mix, blend, dry, and transfer raw materials per product specifications and Standard Operating Procedures SOPs). Ensure products are manufactured within product specifications, meet quality standards, and can ship on time in alignment with the Master Schedule. Responsible for continuous improvement process that results in improved productivity and yields via coordinated efforts with the engineering team. Works with Research and Product Development Engineering on new programs and processing issues, including product transfers during the repeatability process. Provide feedback for process improvement strategies to drive design for manufacturability. Partner cross-functionally with Quality and Engineering Leadership to drive development through the stage gate process. Partner with Quality to ensure manufacturing teams are maintaining product adherences that comply with ISO 13485 and 9001 regulations, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and all safety requirements. Support Quality team with any CAPA-related activity to complete root cause analysis and improve overall quality and performance of the products being manufactured for customers. Comply and follow all Standard Operating Procedures (SOPs) and ensure all quality documentation is completed correctly. Train junior-level extrusion operators and act as the subject matter expert (SME) for all things extrusion. Support Vendor or customer visits as needed.

Who you are:

Associate’s degree required; Bachelor’s degree in business, operations management, engineering or a similar related field preferred. Minimum of Ten (10) years of experience in extrusion, blow molding, or injection molding operations. Demonstrated hands-on working knowledge of Extruders. Considerable knowledge of machine operations that pertain to various polymers and extrusion. Possess knowledge of ISO 13485, 9001, and GMP practices or possess the ability to understand and enforce the practices. Ability to follow and make recommendations and changes to Work Instructions (WIs) and Standard Operating Procedures (SOPs). Ability to measure in all units of measurement and possess a high mathematical aptitude. Considerable knowledge of ERP systems and the manufacturing workflow. Considerable knowledge of the Microsoft Suite products, specifically Excel, Word, PowerPoint, and Outlook. Good presentation skills and the ability to present on a one-to-one basis and to small groups Perks /

Benefits:

Generous Paid Time Off Paid Breaks Annual Bonuses 401k with excellent company match Health Insurance with multiple plans to choose form Paid Short Term and Long Term Disability Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.