MFG & PROCESS TECHNICIAN IV

Job Overview

The Manufacturing and Process Technician IV – Medical Extrusion is a hands-on technical role responsible for operating, setting up, optimizing, and troubleshooting medical-grade polymer extrusion lines used in the production of single and multi-lumen tubing, catheter shafts, heat-shrink tubing, and related extruded medical components.

Extrusion Setup & Operation

• Set up, start, and operate single-screw and co-extrusion lines for medical-grade thermoplastic tubing (PEBAX, Nylon, TPU, PVC, fluoropolymers, PE, PP).
• Configure and optimize process parameters:
  • Barrel temperatures, screw RPM, melt pressure
  • Die and tip selection for OD/ID/wall targets
  • Puller speed/tension, vacuum tank settings, air pressure
• Perform tooling changeovers (dies, tips, tooling) per procedures.
• Operate in-line laser gauging systems (e.g., LaserMike, Beta) for real-time measurement.

Process Control & Quality

• Maintain dimensional performance targets:
  • OD, ID, wall thickness, concentricity, length tolerances
• Conduct and document in-process inspections using calibrated tools.
• Monitor process stability and adjust parameters to maintain capability.

Measurement & Inspection

• Use metrology equipment:
  • Laser/optical micrometers, comparators, calipers, MicroVu/Keyence systems
• Perform cross-sectioning and microscopic evaluation of tubing.
• Inspect for visual defects (voids, surface imperfections, contaminants).
• Conduct functional testing (burst, tensile, hardness, flexibility, kink resistance).

Material Handling & Preparation

• Handle, stage, and track medical-grade resins per material control procedures.
• Operate dryers and verify moisture levels to prevent material degradation.
• Maintain full material traceability for Device History Records (DHR).
• Prepare blends including color masterbatch and radiopaque additives.

Troubleshooting

• Diagnose and resolve extrusion issues such as:
  • Surface defects (melt fracture, die lines)
  • Dimensional drift, eccentricity, surging
  • Resin degradation or discoloration
  • Lumen instability or collapse
  • Puller or process instability

Required Qualifications

• 5-9+ years extrusion experience; minimum 3 years in medical device manufacturing.
• Strong expertise in thermoplastic extrusion setup, operation, and troubleshooting.
• Proficiency in dimensional measurement and inspection tools.
• Experience with controlled documentation (batch records, LHRs).

Preferred Qualifications

• Background in polymer processing or related field.
• Experience with multi-lumen, co-extrusion, or bump tubing.
• Familiarity with radiopaque materials (e.g., barium sulfate).
• Experience with inline laser gauging systems (LaserMike, Zumbach).
• Exposure to catheter or interventional device tubing manufacturing.

Core Competencies

• Technical expertise in extrusion processes
• Strong metrology and quality focus
• Problem-solving and analytical thinking
• Clear communication and teamwork
• High attention to detail and data integrity
• Safety and contamination control mindset

Physical Requirements

• Prolonged standing/walking in a manufacturing environment
• Ability to lift up to 50 lbs regularly
• Manual dexterity for tooling and inspection tasks
• Exposure to heat, fumes, and equipment (PPE required)
• Cleanroom compliance as applicable

Compensation

Competitive base salary commensurate with experience: $70,000 - $104,900 (subject to change dependent on physical location). Total Compensation = Base Salary + Incentive(s) + Benefits.

Benefits

A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.