Senior Medical Tubing Extrusion Engineer
On-siteHarleysville, Pennsylvania, United States
Job Summary
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, and sizing fixtures while serving as technical lead for New Product Introduction, commercialization, and technology transfer projects. Drive continuous improvement initiatives focused on yield, throughput, and cost reduction, and troubleshoot complex process and quality issues using structured problem-solving methodologies. Mentor engineers and technicians to strengthen technical capabilities across the organization.
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.
- Applicants must be legally authorized to work in the United States on an unrestricted basis.
Desired 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.
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