Manager-Medical Tubing Extrusion

5 days ago

Chennai, Tamil Nadu, India e4ea783f-1ef9-4eff-aa07-8d44a283d355 Full time ₹ 25,20,000 - ₹ 42,00,000 per year

Role & responsibilities

  • Manage production of medical-grade thermoplastic tubing using PEBAX, TPU, Nylon, and similar materials.
  • Oversee high-precision micro-extrusion lines and ensure tight tolerance controls are maintained.
  • Implement and maintain Statistical Process Control (SPC) practices across extrusion and braiding processes.
  • Supervise continuous braiding operations for reinforced catheter and medical tubing.
  • Coordinate inline extrusion-braiding integration and ensure synchronization of equipment and processes.
  • Ensure compliance with ISO 13485, GMP, and FDA 21 CFR Part 820 standards.
  • Lead production planning, team supervision, and performance management.
  • Develop SOPs, batch records, and support validation protocols including IQ, OQ, PQ.
  • Troubleshoot processing issues, material variations, and tooling concerns.
  • Drive continuous improvement initiatives in quality, efficiency, and cost reduction.
  • Collaborate with QA, R&D, and maintenance teams to achieve product and process excellence.
  • Support internal and customer audits with robust documentation and corrective actions.

Preferred candidate profile

  • Thermoplastic Micro-Extrusion (PEBAX, TPU, Nylon)
  • Continuous Medical Braiding Operations
  • Inline Extrusion-Braiding Synchronization
  • SPC (Statistical Process Control)
  • Tooling and Die Design for Small-Diameter Tubing
  • Tight Tolerance Process Control
  • Cleanroom Manufacturing (ISO Class 7/8)
  • ISO 13485 / FDA GMP Compliance
  • Process Validation (IQ/OQ/PQ)
  • Lean Manufacturing, 5S, Kaizen
  • Team Leadership & Operator Training
  • Audit Preparedness & Documentation Control
  • ERP/MES System Familiarity

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