Viral Thakkar

About Viral Thakkar

Over 20 years experience developing and manufacturing innovative medical devices and systems.Management and leadership of all phases of Medical Device Design and Development from market definition through production and release. Responsible for Manufacturing Operations, Research and Development, Quality Operations, Facilities, Continuous Improvement, and Planning functions to continuously improve the overall business performance metrics.Organize, develop, grow, mentor and coach product development organizations and individuals.

Experience

1. Chief Operating Officer

   Lungpacer Medical

   Dec 2023 — Present · Exton, PA, US

   Responsible for the management and leadership of all phases of design and development of disposable trans-vascular diaphragm pacing system from market definition through production and release.Responsible for Manufacturing, Research & Development, Supply Chain, Quality, Facilities, IT, Continuous Improvement, and Planning functions to continuously improve the overall business performance metrics.Responsible for managing company Intellectual Property.

Education

• Missouri University of Science and Technology

  M.S., Mechanical Engineering

  2002 — 2004

• Nagpur University

  B.E., Mechanical Engineering

Skills

• Fmea
• Biomedical Engineering
• Manufacturing
• Validation
• Product Development
• Testing
• R&D
• Medical Devices
• Quality System
• Cross-Functional Team Leadership
• Iso 14971
• Solidworks
• Fda
• Research and Development (R&D)
• Design for Manufacturing
• Iso 13485
• Product Design
• Design Control
• Injection Molding