Vijesh Kizhuppadath, CMDP

Experience

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  Relisys Medical Devices Limited

  Jan 2009 - Oct 2010

  Executive - Production

  • Well experience in Extrusion process for manufacturing of medical device tubing’s with various types of polymer.• Hands on experience in precision tube extrusion for PTCA / PTA catheters with Nylon, PEBAX and PET polymer.• Hands on experience in single lumen and multi- lumen extrusion with Poly Urethane for Dual lumen catheter.• Well knowledge about Braided Reinforced catheter extrusion which is a core part of Diagnostic, Aspiration and Guiding catheter. • Hands on experience in Braiding process.• Production Planning and execution as per requirement.• Preventive maintenance of various types of Equipment and machine.• Experience in production related documentation, i.e, SOP’s, work instructions, batch manufacturing records.• Process Validation and Document preparation as per ISO, GMP standard requirement.• Experienced working in clean room for manufacturing of Medical devices Show less

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  Biorad Medisys Pvt Ltd

  Nov 2010 - Jun 2011

  Incharge - Extrusion

  • Responsible for Extrusion department for production planning and execution.• Hands on experience in processing of commodity, engineering, high performance polymers.• Experience in single and multi lumen tubing extrusion for urology, radiology, gastroenterology catheters.(Urethral catheter, PCN catheter, Malecot catheter, Double J stents, Dilators, etc).

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  Relisys Medical Devices Limited

  Jul 2011 - Jun 2016

  Assistant Manager - Production & NPD

  • Project leader for Design and Development of indigenously developed Coronary Angiographic/Diagnostic Catheter• Well experienced as a Process Development Engineer for Aspiration Catheter and Guiding Catheter.• Generate and implement on-site manufacturing IQ, OQ and PQ protocols, processes and systems that conform to design, manufacturing, FDA regulatory and safety requirements• Training manufacturing personnel on improvements and modifications to manufacturing operations and related documentation like, SOPs, Work Instructions, Inspection Sheets.• Participation in design and process FMEA.• Documentation updates to product Design History Files• Development and execution of bench tests for prototype performance characterization• Providing input to Engineering drawing creation and review• Development and qualification of test methods and equipment for product characterization and design verification• Coordinate in Design and development of fixtures and tooling for manufacturing.• CAPA & Process improvement• Production planning & execution according to marketing requirement.• Responsible for Catheter assembling production.• Hands on experience in catheter shaft grinding and distal shape setting.• Hands on experience in Radio Frequency (RF) welding for various applications, like catheter welding, taper tipping, tip deburring, etc.• Experience in mechanical and In-vitro testing of catheters.• Overseeing conformance to the organization’s Quality Accredited Standards. • Completing a range of related Administration and Reporting functions. Show less

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  VASMED TECHNOLOGIES LIMITED

  Jul 2016 - Nov 2022

  Manager - Production, planning & control

  • PTCA catheter and guide wire development and setting manufacturing line• Invasive Pressure monitoring and imaging device development (FFR Catheter).• ETO sterilizer selection, installation, commissioning and validation.• Fluro polymer(PTFE) and Hydrophilic coating for catheter and guide wire surface improvement• Additive manufacturing/ Rapid prototyping for medical console.• Process validation and product verification• Medical electronics devices• Material management• Custom machine manufacturing for medical device assembly line• Supplier contact and follow up for consist supply of raw materials• Equipment customization for production line• Clean room installation and validation as per – ISO 14644• Product Risk Management – ISO 14971.• Manpower hiring and training Show less

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  Medical Device Manufacturing company

  Nov 2022 - now

  Sr. Manager Production

  PTCA balloon catheter manufacturing Plant operation Quality Management System ISO13485: 2016Suplier development and material management New product development & Project Management Manpower hiring and development