Manager-Medical Tubing Extrusion & Braiding (Thermoplastics)

S3V Vascular Technologies

8 - 10 years

9 - 12 Lacs

chennai

Posted:4 weeks ago| Platform:

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Skills Required

plastic extrusion polymer engineering iso standards plastic engineering plastic technology medical devices

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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