Pavan T

Experience

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  VISHNU PRIYA INDUSTRIES PRIVATE LIMITED

  Jun 2017 - Jun 2018

  Trainee

  working as a trainee

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  Bangalore Metallurgicals Private Limited

  Jul 2018 - Oct 2018

  Trainee

  Worked as quality engineer.

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  JHY TECHSERVE PRIVATE LIMITED

  Oct 2018 - Dec 2020

  Production And Quality Engineer

  Responsible for incoming, process and final quality, route card and traceability of parts.Preparing Documents like Control plan, PFMEA, SOP and Visual checklist.NC Verification & Analysis of Corrective & Preventive action (CAPA) and Problem solving using 8D Problem solving Technique.Responsible for 4M change monitoring and relevant documents.Performing MSA (Variable, Attribute) and Online SPC.Preparing the production planning, Raw material planning and supplier schedules.

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  ADROIT USA medical device pvt ltd

  Dec 2020 - Aug 2022

  Quality Engineer

  Review & Involving in the Validations (IQ- Installation Qualification / OQ- Operational Qualification / PQ- Performance Qualification), Test protocol, and Test report for the new process.Review & Implement PFMEA, Process Flow Chart & Work instructions.Preparing Device History Record (DHR) and its supporting records.NC Verification & Analysis of Corrective & Preventive action (CAPA) and Problem solving using 8D Problem solving Technique.Preparing Documents like Control plan, SOP and Visual checklist.To Establish QMS, Implement, Maintain & Improve in accordance with ISO 13485:2016, ISO 14971, Application of Risk Management to Medical Devices.Knowledge on Design control and Knowledge on clean room requirements.Having knowledge about multiple processes like Injection moulding, Laser welding, sharpening, cylindrical grinding, Automation of gluing & UV curing, Flaring, End forming, Bending, Pad printing, Ultrasonic cleaning, Electropolishing, passivation and Assembly operations of biopsy devices. Show less

• 

  Tata Elxsi

  Aug 2022 - now

  Senior Engineer

  Performing gap assessments as per EU MDR Annex I GSPR, and Annex II Technical Documentation. Preparing Risk assessment/Hazard analysis by identifying hazards, foreseeable sequence of events that lead to hazardous situations and harms, estimating severity and probability, and evaluating and controlling the risks according to ISO 14971. Executing MDR classification determination for medical devices based on their intended use per EU MDR Annex VIII Classification Rules.Using SolidWorks to access 3D surfaces of medical equipment or device that come into direct or indirect contact with patients.Understanding medical device operation, categorizing surface area into external surface, filled lumens, unfilled lumens, mated surface.Experience in Hip & Knee Implants. Show less