Manufacturing Technician

The Catheter and Balloon Manufacturing Technician is responsible for the precision manufacturing, assembly, and testing of medical-grade catheters and balloon catheter systems used in critical cardiovascular and interventional procedures. This position requires meticulous attention to detail and a strong commitment to quality, as the products manufactured directly impact patient safety and clinical outcomes. The technician will operate specialized equipment for catheter extrusion, balloon forming, bonding, and assembly while maintaining strict adherence to cleanroom protocols and FDA/ISO quality standards. The ideal candidate possesses excellent hand-eye coordination, a thorough understanding of medical device manufacturing processes, and the ability to work precisely within tight tolerances in a highly regulated environment. 

DUTIES AND RESPONSIBILITIES: 

Catheter Manufacturing: 

• Operate catheter extrusion equipment to produce multi-lumen tubing with precise dimensional specifications and material properties 
• Perform catheter shaft preparation including cutting, grinding, skiving, and surface treatment operations 
• Execute tip forming processes using heat forming equipment to create atraumatic catheter tips 
• Apply radiopaque marker bands using precise placement fixtures and bonding techniques 
• Conduct in-process dimensional inspections using calipers, microscopes, and specialized measurement tools 

Balloon Manufacturing & Processing: 

• Perform balloon bonding operations, including proximal and distal bond attachments to catheter shafts 
• Execute balloon folding and wrapping procedures using manual and semi-automated equipment 
• Conduct bond strength testing using pull testers and document results per established protocols 
• Inspect balloons for defects including pinholes, wrinkles, and dimensional non-conformance 

Assembly Operations: 

• Assemble complete catheter systems including hubs, strain reliefs, guidewire lumens, and inflation devices 
• Perform adhesive bonding, thermal bonding, and mechanical crimping operations 
• Integrate hemostasis valves, Luer fittings, and other catheter components with precision 

Quality Control & Testing: 

• Conduct functional testing including burst pressure testing, rated burst pressure verification, and leak testing 
• Perform tensile and bond strength testing on critical joints and connections 
• Execute compliance testing to verify balloon performance characteristics 
• Document all test results accurately in production batch records and ERP systems 

Cleanroom Operations: 

• Maintain Class 7/8 cleanroom environments following strict gowning, cleaning, and contamination control procedures 
• Monitor and document environmental conditions including particle counts and temperature/humidity levels 
• Handle sterile and non-sterile components using appropriate aseptic techniques 

Equipment Maintenance & Validation: 

• Perform routine preventive maintenance on catheter and balloon manufacturing equipment 
• Support Installation Qualification (IQ) and Operational Qualification (OQ) activities for new equipment 
• Calibrate measurement and test equipment according to established schedules 
• Troubleshoot equipment malfunctions and coordinate repairs with maintenance and engineering teams 

Documentation & Compliance: 

• Utilize Epicor ERP system for work order processing, material transactions, and inventory management 
• Participate in deviation investigations and implement corrective actions 
• Support complaint investigations by analyzing returned products and providing technical input 

Continuous Improvement: 

• Identify opportunities for process optimization, yield improvement, and cycle time reduction 
• Participate in cross-functional teams focused on manufacturing excellence initiatives 
• Suggest fixture improvements and tooling modifications to enhance quality and efficiency 

Other Responsibilities: 

• Support training of new manufacturing technicians/operators on catheter and balloon processes 
• Participate in equipment qualifications and process validations 
• Assist with special projects and prototype builds as assigned 
• Potential travel to international manufacturing sites (Costa Rica, China, Vietnam) 

Education: 

• High school diploma or GED required 
• Associate degree in Manufacturing Technology, Biomedical Equipment Technology, Polymer Science, or related technical field strongly preferred 
• Certificate programs in medical device manufacturing or catheter technology are advantageous 

Experience: 

• Minimum 3-5 years of hands-on experience in medical device manufacturing, specifically with catheter and/or balloon catheter production 
• Demonstrated experience with extrusion processes, balloon forming, and precision assembly operations 
• Prior experience in a Class 7/8 cleanroom manufacturing environment required 
• Experience with single-use disposable medical devices such as vascular access devices, drainage catheters, or interventional catheters 

Technical Skills: 

• Catheter Expertise: Proficient in catheter manufacturing processes including extrusion, heat forming, bonding, and coating applications 
• Balloon Technology: Hands-on experience with balloon blow molding, folding techniques, and balloon-to-catheter bonding 
• Precision Tools: Skilled in the use of micrometers, calipers, optical comparators, and microscopes for dimensional verification 
• Testing Equipment: Experience operating pull testers, burst pressure testers, leak testers, and other specialized medical device test equipment 
• Hand Tools: Proficient with precision hand tools including scalpels, crimpers, heat guns, and torque drivers 
• ERP Systems: Working knowledge of Epicor or similar manufacturing execution systems 
• Microscopy: Ability to perform visual inspections under magnification to identify defects and verify quality 

Regulatory Knowledge: 

• Strong understanding of FDA Quality System Regulation (21 CFR Part 820) and cGMP requirements 
• Familiarity with ISO 13485 medical device quality management standards 
• Knowledge of Design History File (DHF) and Device Master Record (DMR) requirements 
• Understanding of biocompatibility requirements for patient-contacting materials (ISO 10993) 

PHYSICAL DEMANDS AND WORK ENVIRONMENT: 

• Duration: Must be able to stand for extended periods (up to 8-10 hours per shift) at workstations and manufacturing equipment 
• Manual Dexterity: Frequent use of hands and fingers for precision assembly, manipulation of small components, and tool operation 
• Vision Requirements: Close vision and color vision required; ability to work under magnification for extended periods; ability to adjust focus between near and far distances 
• Lifting: Ability to occasionally lift and carry up to 35 pounds (equipment, material containers, component boxes) 
• Cleanroom Environment: Must work in Class 7/8 cleanroom conditions requiring full gowning (hood, coveralls, gloves, safety glasses, shoe covers); tolerance for working in climate-controlled environments with limited fresh air circulation 
• Repetitive Motion: Frequent repetitive hand and wrist movements associated with catheter assembly and testing operations 
• ESD Awareness: Work in controlled Electrostatic Discharge (ESD) environments; must wear ESD protective equipment including wrist straps and ESD-safe footwear 
• Chemical Exposure: Potential exposure to adhesives, solvents, and cleaning agents used in manufacturing processes (proper PPE provided) 
• Equipment Hazards: Work near moving mechanical parts, heated equipment, and pressurized systems; adherence to all safety protocols required 
• Sitting/Standing: Must alternate between sitting and standing positions depending on the specific manufacturing operation 
• Reaching/Bending: Occasional reaching, bending, and stooping to access materials, equipment controls, and workstations 

• The expected salary for this position is between $65,000 - $75,000 annually, depending on experience, skills, qualifications.
• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays once a month!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.