Senior Medical Tubing Extrusion Engineer

Harleysville, PA

Full Time

Experienced

Senior Medical Tubing Extrusion Engineer
Onsite Position
Relocation assistance is not available

Join Our Team
Join a growing medical device manufacturing organization where your technical expertise will directly impact the development and production of innovative healthcare technologies. As a Senior Medical Tubing Extrusion Engineer, you will serve as the technical leader for extrusion process development, validation, optimization, and commercialization activities. This role offers the opportunity to work on complex medical tubing products, influence manufacturing strategy, mentor technical talent, and drive continuous improvement in a highly regulated environment.

Position Summary
The Senior Medical Tubing Extrusion Engineer serves as the subject matter expert for medical tubing extrusion processes and technologies. This individual leads process development, validation, equipment and tooling improvements, and new product introduction activities while partnering closely with Manufacturing, Quality, Maintenance, Supply Chain, Project Management, and Commercial teams.

This role combines hands-on engineering expertise with technical leadership and offers the opportunity to influence both current operations and future manufacturing capabilities.

How You Will Contribute

Lead the development, optimization, validation, and sustainment of medical tubing extrusion processes to ensure product quality, efficiency, and compliance.
Design, develop, qualify, and maintain extrusion tooling, including dies, tips, mandrels, sizing fixtures, and downstream tooling.
Lead process and equipment validation activities, including IQ, OQ, PQ, process characterization, and capability studies.
Serve as the technical lead for extrusion-related New Product Introduction (NPI), commercialization, scale-up, and technology transfer projects.
Drive continuous improvement initiatives focused on yield improvement, process capability, throughput, cost reduction, and operational excellence.
Troubleshoot complex process, tooling, equipment, and product quality issues using structured problem-solving methodologies.
Conduct root cause investigations and implement effective corrective and preventive actions.
Develop and maintain engineering documentation, validation reports, SOPs, work instructions, and process standards.
Evaluate manufacturability, capacity requirements, and technical feasibility for new business opportunities and customer programs.
Mentor and train engineers, technicians, and manufacturing personnel to strengthen technical capabilities throughout the organization.
Support customer audits, supplier assessments, technical reviews, and regulatory inspections.
Evaluate and implement new materials, equipment, automation technologies, and manufacturing methods to expand organizational capabilities.
Lead cross-functional projects that support strategic manufacturing and business objectives.

Required Qualifications

Bachelor's degree in Mechanical Engineering, Polymer Engineering, Chemical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related engineering discipline.
7+ years of experience in extrusion engineering, polymer processing, medical device manufacturing, or a related manufacturing environment.
Demonstrated expertise in medical tubing extrusion process development, optimization, and troubleshooting.
Strong knowledge of thermoplastics, polymer behavior, and extrusion processing principles.
Experience designing and developing extrusion tooling, including dies, tips, mandrels, and sizing systems.
Experience leading process and equipment validations, including IQ, OQ, and PQ activities.
Strong understanding of Design of Experiments (DOE), Statistical Process Control (SPC), process characterization, and capability analysis.
Experience conducting root cause investigations and implementing corrective and preventive actions.
Strong technical writing, project management, and communication skills.
Demonstrated ability to lead technical projects and mentor engineers, technicians, and manufacturing personnel.

Preferred Qualifications

Experience in medical device manufacturing.
Knowledge of FDA Quality System Regulations (QSR), ISO 13485, Good Manufacturing Practices (GMP), Design Controls, Risk Management, and Change Control processes.
Experience with complex medical tubing products, including multilumen, tapered, reinforced, microbore, and specialty extrusions.
Experience supporting NPI, customer qualification, commercialization, and technology transfer activities.
Lean Six Sigma Green Belt or Black Belt certification.
Experience with SolidWorks or equivalent CAD software.
Experience supporting technical quoting and manufacturability assessments.

Work Authorization Requirement: Applicants must be legally authorized to work in the United States on an unrestricted basis. The Company does not sponsor employment visas or provide immigration-related sponsorship now or in the future. Candidates requiring current or future sponsorship for employment authorization are not eligible for consideration.

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This position is fully onsite in Harleysville, PA. Are you able and willing to work onsite on a full-time basis?*

This position does not provide relocation assistance. Are you able to commute to or relocate to the Harleysville, PA area at your own expense?*

How many years of experience do you have working directly with medical tubing extrusion processes?*

Have you led or directly supported extrusion process and equipment validations (IQ,OQ,PQ)?*

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Please describe your experience with medical tubing extrusion, including the types of tubing products you have supported.*

Which thermoplastic materials have you worked with in an extrusion environment?*

Which extrusion tooling have you designed, developed, or qualified?*

What role have you played in New Product Introduction (NPI) activities?*

What is the most significant process improvement you have implemented in an extrusion operation? Please include measurable results if possible.*

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Senior Medical Tubing Extrusion Engineer

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