Pavan B P

About Pavan B P

Strong engineering professional with a Bachelor of Engineering - BE focused in Mechanical Engineering from P E S College of Engineering, MANDYA.Experienced Advanced Manufacturing Engineer with a demonstrated history of working in the manufacturing industry in tooling and fixtures design and process (product and equipment) engineering.Knowledge of ISO 13485, Medical device Quality System Regulation – FDA 21CFR Part 820, MDR 803, ISO 14971, FMEA, Production and process controls, Lean and six sigma methodologies and Engineering Design.Skilled in PTC Creo, windchill PLM, manufacturing technologies and Mechanical Engineering.

Experience

1. Mdr Vigilance Specialist

   美敦力

   Mar 2020 — Present · Hyderabad, IN

   Responsible for Medical devices surveillance program including the intake, protocol development, evaluation, processing, failure investigation, adverse reports and follow-up on product complaints, participation in the resolution of any legal liability and in complying with government regulations.Ensured complete and accurate maintenance and reporting of Medical Device Reports (MDRs) and facilitated continuous improvement of regulatory and quality systems in post market quality process to ensure regulatory compliance and complaint handling/medical device reporting requirements.Acted as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.Responsible for Timely closure of complaints from Intake to closure including Investigations and US-FDA and EU MDR regulatory reports submission for Medtronic Spinal business.Supported Continuous Process improvement and action plans on gaps identified to improve quality score in complaint handling process.Supported Testing and Implementation of Gandalf tool to Spinal team (Automation tool for processing complaints faster) and certified as Technology planning team SME for Spinal complaint handling.Ensured record documentation is maintained in a constant state of audit readiness per internal policies.Facilitated and interpret risk management documentation as it applies to the complaint event.Certified as primary SME for Medicrea complaint handling and supported integration and transition of complaint handling from Medicrea to Medtronic Spinal BU.

Education

• P. E. S. College of Engineering, Mandya

  Bachelor of Engineering - BE, Mechanical Engineering

  2014 — 2018