Qureos Mentor

Access Vascular, Inc.

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 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 &amp; Optimization
 
 
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 Work hands-on to develop, validate, and implement extrusion processes to support new product development.
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 Optimize existing extrusion processes to accommodate scale-up of existing products.
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 Author and execute process validations (IQ/OQ/PQ) as required.
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 Implement data-driven process monitoring and control techniques.
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 Provide hands-on technical support to production extrusion technicians as-needed.
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 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).
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 Identify and resolve nonconformance's and other technical and quality related issues.
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 Lead continuous improvement initiatives to reduce manufacturing costs, improve yield, and minimize scrap.
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 Tooling, Equipment &amp; Automation
 
 
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 Design and source extrusion dies and related tooling and fixtures to support production and new product development.
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 Source new extrusion process equipment to support increased capacity, improved control and consistency, and changing equipment needs associated with new product development and introduction.
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 Identify opportunities for automation of extrusion processes and related inspections to improve efficiency and increase capacity.
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 Troubleshoot equipment issues and implement corrective actions.
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 Develop capital equipment proposals to support extrusion needs.
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 Establish standard work procedures and equipment operating parameters.
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 Project &amp; Team Leadership
 
 
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 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.
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 Lead or participate in cross-functional activities to resolve quality issues, including material review board (MRB), customer complaint investigations, and CAPA related activities.
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 Support product design and development activities and regulatory submissions as-needed.
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 Serve as strong team player, supporting and assisting supervisor and colleagues when necessary and complying with all work safety rules and regulations.
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 Skills and Qualifications
 
 
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 Bachelor&rsquo;s degree in Plastics Engineering, Polymer Science, or a related discipline.
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 Minimum of 3 years of medical profile extrusion experience in an FDA regulated and/or ISO 13485 manufacturing environment.
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 Prior experience leading the design, development, and validation of extrusion processes and related fixtures and tooling.
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 Proven project management experience, with the ability to lead cross-functional initiatives.
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 Proficiency in SolidWorks, including demonstrated expertise in designing fixtures and tooling.
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 Strong organizational skills and ability to shift priorities and manage multiple tasks in a fast-paced, dynamic environment.
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 Excellent verbal and written communication skills; capable of effectively communicating across all levels and disciplines of the organization.
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 Six Sigma Green Belt or Black Belt (preferred).
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 Experience with plastics processing techniques such as extrusion, injection molding, and fiber forming (preferred).
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</div>

Extrusion Engineer

Join Access Vascular, Inc. and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Access Vascular, Inc.

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Extrusion Engineer