Join a growing medical device team supporting the manufacturing of high-precision catheter and balloon systems used in cardiovascular and interventional procedures. This role involves hands-on manufacturing, assembly, and testing of complex devices in a cleanroom environment while following FDA/ISO quality standards.
Manufacture and assemble catheter shafts, balloon components, and full catheter systems
Perform extrusion, heat forming, bonding, folding, and precision assembly operations
Conduct in-process inspections and functional testing (burst, leak, tensile)
Maintain cleanroom standards (Class 7/8) and follow all documentation requirements
Support equipment calibration, troubleshooting, and continuous improvement projects
3–5 years of medical device manufacturing experience; catheter or balloon experience strongly preferred
Hands-on skills with microscopes, measurement tools, and catheter/balloon test equipment
Experience in cleanroom manufacturing and working with small, delicate components
Understanding of FDA QSR, ISO 13485, and GMP requirements
Strong attention to detail, manual dexterity, and ability to follow detailed work instructions
Associate degree or technical certification in manufacturing, biomedical technology, polymers, or related field
Experience with extrusion, balloon forming, or bonding processes
Familiarity with ERP systems and detailed documentation practices
