Extrusion Engineer

Extrusion Engineer

Access Vascular, Inc.

Billerica, MA

Summary

The Extrusion Engineer will play a pivotal, hands-on role in developing and optimizing extrusion processes and related operations for profile extrusion of novel biomaterials used in veinous access medical devices. This position offers a unique opportunity to contribute to an early-stage, innovation-driven company with strong potential for career growth. The ideal candidate brings deep expertise in extrusion process development, polymer processing, and scalable manufacturing, and thrives in a fast-paced environment focused on continuous improvement.

Essential Duties and Responsibilities

As a key member of the Operations team, you will be responsible for all extrusion-related activities. The position requires the ability to balance new product development and routine production needs, with an eye towards future scale-up and continuously improving in-house capabilities. Your core responsibilities will include:

Process Development & Optimization

• Work hands-on to develop, validate, and implement extrusion processes to support new product development.
• Optimize existing extrusion processes to accommodate scale-up of existing products.
• Author and execute process validations (IQ/OQ/PQ) as required.
• Implement data-driven process monitoring and control techniques.
• Provide hands-on technical support to production extrusion technicians as-needed.
• Write clear, concise work instructions and process documentation to support commercial medical device manufacturing, (including inspection procedures, test protocols, assembly drawings, equipment control documentation, and component drawings).
• Identify and resolve nonconformance's and other technical and quality related issues.
• Lead continuous improvement initiatives to reduce manufacturing costs, improve yield, and minimize scrap.

Tooling, Equipment & Automation

• Design and source extrusion dies and related tooling and fixtures to support production and new product development.
• Source new extrusion process equipment to support increased capacity, improved control and consistency, and changing equipment needs associated with new product development and introduction.
• Identify opportunities for automation of extrusion processes and related inspections to improve efficiency and increase capacity.
• Troubleshoot equipment issues and implement corrective actions.
• Develop capital equipment proposals to support extrusion needs.
• Establish standard work procedures and equipment operating parameters.

Project & Team Leadership

• Manage extrusion engineering projects from concept through execution, including developing comprehensive project plans and timelines. Monitor project performance and ensure alignment with short- and long-term organizational goals.
• Lead or participate in cross-functional activities to resolve quality issues, including material review board (MRB), customer complaint investigations, and CAPA related activities.
• Support product design and development activities and regulatory submissions as-needed.
• Serve as strong team player, supporting and assisting supervisor and colleagues when necessary and complying with all work safety rules and regulations.

Skills and Qualifications

• Bachelor’s degree in Plastics Engineering, Polymer Science, or a related discipline.
• Minimum of 3 years of medical profile extrusion experience in an FDA regulated and/or ISO 13485 manufacturing environment.
• Prior experience leading the design, development, and validation of extrusion processes and related fixtures and tooling.
• Proven project management experience, with the ability to lead cross-functional initiatives.
• Proficiency in SolidWorks, including demonstrated expertise in designing fixtures and tooling.
• Strong organizational skills and ability to shift priorities and manage multiple tasks in a fast-paced, dynamic environment.
• Excellent verbal and written communication skills; capable of effectively communicating across all levels and disciplines of the organization.
• Six Sigma Green Belt or Black Belt (preferred).
• Experience with plastics processing techniques such as extrusion, injection molding, and fiber forming (preferred).