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Extrusion Process Specialist
2 months ago
Position Overview
The Extrusion Process Engineer is responsible for the planning, design, and execution of projects within the extrusion manufacturing sector, employing methodologies such as Six Sigma, Lean, and DMAIC. This role focuses on the creation and implementation of innovative products and processes aimed at enhancing productivity, minimizing customer complaints, and lowering operational costs. The engineer will lead initiatives to decrease scrap rates, elevate quality standards, and streamline processes. Collaboration with various functions within the Spectrum Plastics Group, as well as external vendors, is essential for the successful implementation of new capital manufacturing equipment and processes that enhance production efficiency and capacity.
Key Responsibilities
- Design and execute new tooling, process enhancements, product development processes, and cost/value optimization projects.
- Oversee the selection, procurement, installation, start-up, and qualification of new capital equipment, tooling, and fixtures for medical device manufacturing.
- Lead cost and quality improvement initiatives that align with manufacturing objectives and effectively reduce COGS.
- Revise and implement manufacturing documentation in line with process enhancements and new equipment installations.
- Develop and manage project plans by identifying necessary tasks, resources, timelines, and budgetary requirements.
- Engage in the selection process for extrusion equipment and tooling vendors.
- Create equipment specifications based on product and process requirements.
- Ensure timely project completion within budget by monitoring all project activities and providing management with status reports.
- Provide vendors with comprehensive documentation and sample components necessary for the design, fabrication, troubleshooting, and acceptance of equipment.
- Establish statistically valid acceptance and installation protocols in collaboration with manufacturing personnel and Quality Assurance.
- Verify that all test methods outlined in acceptance or installation protocols are clearly defined and utilize acceptable measurement systems.
- Conduct equipment acceptance testing and document the results.
- Assist in the installation and validation of new equipment.
- Identify training needs for personnel operating new equipment and develop relevant training materials.
- Adhere to all safety regulations, policies, and procedures as mandated by local, state, federal, and Spectrum Plastics Group standards.
- Follow quality policies and procedures consistently, applying sound quality assurance principles as outlined in the site quality manual and ISO 13485:2016 standards.
Qualifications
- Bachelor's degree in Mechanical, Chemical, or Material Science is preferred.
- Hands-on approach with a commitment to supporting production operations.
- Strong knowledge of extrusion processes and plastic materials, with the ability to conduct material research.
- Excellent communication and interpersonal skills, capable of engaging with employees at all levels.
- Proficient documentation skills, with familiarity in ISO 13485 being advantageous.
- A minimum of three years of experience in medical device manufacturing or extrusion/molding processes.
- Proficient in Microsoft Office, CAD software, and Minitab.
- Experience in CNC fabrication and machining processes is a plus but not mandatory.
- Ability to understand customer requirements and applications.
- Six Sigma Greenbelt or equivalent certification is beneficial but not required.
Physical Requirements
- Ability to lift up to 50 pounds.
- Capability to walk, stand, and sit for extended periods.
- Prolonged periods of viewing computer screens.
Work Environment
- Office, manufacturing, clean room, and warehouse settings.