Michael Page
- Career Growth in a Specialized, Expanding Facility.
- Impactful Work in Life-Saving Technologies.
A leading medical device manufacturer is expanding its New Jersey operations and hiring a full-time Extrusion Engineer. This company specializes in polymer-based medical components, with core capabilities in medical extrusion, injection molding, catheter assembly, balloon forming, and more. With a focus on complex, high-precision medical device manufacturing, they serve some of the most technically advanced markets in the healthcare industry.
Job Description
- Develop, optimize, and troubleshoot extrusion processes for medical tubing, catheter components, and other polymer-based medical products
- Drive continuous improvement in extrusion line performance, material selection, and processing parameters
- Lead or assist in IQ, OQ, and PQ validations for new extrusion processes
- Collaborate with R&D, quality, and production teams to transfer medical device designs into scalable, validated extrusion processes
- Analyze production data, identify extrusion issues, and implement corrective actions to improve yield and process control
- Ensure full compliance with ISO 13485 and other medical device regulatory standards
- Maintain detailed documentation of extrusion process parameters, equipment setup, and validations
- Support extrusion development for both low-volume, high-complexity and high-volume product lines
The Successful Applicant
- Bachelor's degree in Engineering (Mechanical, Biomedical, Plastics, or similar) or equivalent hands-on extrusion experience
- 3-7+ years of extrusion engineering or polymer processing experience, preferably in medical device manufacturing
- Strong understanding of medical extrusion processes, including tubing, profile, or film extrusion
- Proven experience with process validation, design controls, and regulated manufacturing environments
- Knowledge of ISO 13485, FDA QSR, and good documentation practices
- Familiarity with thermoplastics, materials science, and medical-grade polymers
- Comfortable working cross-functionally in fast-paced, deadline-driven teams
- Experience in catheter, balloon, or tubing extrusion is highly preferred
- Competitive compensation and full benefits
- Opportunity to work with cutting-edge extrusion equipment and materials
- Direct impact on life-saving medical device technologies
- Supportive team environment that values engineering excellence, continuous improvement, and professional development
- Growth potential within a rapidly expanding company investing in new technologies and infrastructure
Contact
Grace Mcgrady
Quote job ref
JN-072025-6779819