Manager - Medical Tubing Extrusion & Braiding (Thermoplastics)

Company Description

S3V Vascular Technologies is dedicated to becoming a global leader in medical technology, with a mission to enhance the lives of patients with cardiovascular diseases. Fueled by a deep understanding of cardiovascular conditions and partnerships with physicians worldwide, the company develops innovative medical solutions to transform treatment outcomes. S3V Vascular brings global best practices to the Indian healthcare landscape, focusing on advancing medical devices, training physicians, and raising patient awareness. With a team of skilled professionals, S3V is committed to achieving ambitious goals to lead the market in its areas of expertise.

Role Description

This is a full-time, on-site role located in Chennai for a Manager - Medical Tubing Extrusion & Braiding (Thermoplastics). The Manager to lead our operations focused on high-precision medical tubing using thermoplastic extrusion and continuous braiding processes. The role involves working with advanced micro extrusion lines to process materials like PEBAX, TPU and Nylon as well as managing the braiding operations for reinforced catheter shafts and tubing. The successful candidate must demonstrate a strong track record of managing cleanroom manufacturing, tight tolerance control, SPC and regulatory compliance in the medical device industry.

Key Responsibilities

• Proficiency in Medicine and knowledge of related regulatory requirements
• 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. 

Qualifications

• Proficiency in Medicine and knowledge of related regulatory requirements
• Bachelor’s degree or Diploma in Mechanical, Polymer, or Industrial Engineering.
• 8+ years of experience in medical tubing extrusion and/or braiding, with a focus on thermoplastics.
• Hands-on experience operating and managing micro-extruders and braiding machines (e.g., Steeger, Wardwell).
• Strong knowledge of cleanroom operations and regulatory requirements.
• Experience with SPC, OEE tracking, and production analytics.
• Proficient in process validation, change control, and deviation handling.
• Excellent leadership, team-building, and cross-functional coordination skills.

Preferred Industry Experience

• Medical device manufacturing (catheters, neurovascular, cardiovascular tubing).
• Micro-extrusion and braiding of reinforced medical tubing.
• High-performance thermoplastic and braided component processing in a cleanroom.