Process Development Engineer

Job Summary

The Extrusion/Process 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 internal team, as well as with outside vendors to coordinate implementation of new capital manufacturing equipment and processes to optimize production and increase capacity.

Essentials 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, timelines, 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 site safety regulations, policies, and procedures
• 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.

Qualifications

• 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.

Compensation:

$45.00/hr to $55.00/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Healthcare benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, financial protection benefits, as well as HSA, FSA, and DCFSA account options. 401k retirement account access is offered starting on the 90th day with employer matching after one year of service. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.