Manager-Medical Tubing Extrusion (Fluoropolymers)

S3V Vascular Technologies

8 - 10 years

9 - 12 Lacs

chennai

Posted:3 weeks ago| Platform:

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Skills Required

ptfe polymer compounding iso plastic extrusion polymer engineering medical extrusion etfe

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Responsibilities

Manage daily production of medical-grade tubing using Ram and Fluoropolymer Thermoplastic extrusion technologies.
Ensure adherence to cleanroom standards and regulatory compliance for medical device manufacturing.
Develop and implement production plans to meet volume, cost, and quality objectives.
Optimize process parameters for materials like PTFE, FEP, PFA, and other medical-grade fluoropolymers.
Lead extrusion trials for new product development and support scale-up activities.
Ensure compliance with ISO 13485, GMP, and FDA 21 CFR Part 820 requirements.
Mentor and manage teams of engineers, supervisors, and operators.
Drive OEE improvement, scrap reduction, and cost optimization initiatives.
Implement lean manufacturing, 5S, and continuous improvement practices.
Collaborate with R&D, QA, and maintenance for cross-functional process excellence.
Maintain robust documentation of batch records, deviations, and CAPA.
Prepare and submit production metrics, reports, and dashboards.

Desired Candidate Profile

Fluoropolymer Processing Expertise (PTFE, FEP, PFA, etc.)
Ram Extrusion & Thermoplastic Extrusion
Cleanroom Extrusion Operations (ISO Class 7 or 8)
Process Validation (IQ/OQ/PQ)
Extrusion Tooling & Die Design Knowledge
GMP Compliance & ISO 13485 Standards
Medical Tubing Specifications & Tolerances
Root Cause Analysis / CAPA Implementation
OEE, Yield & Scrap Reduction Techniques

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