Viral Thakkar
Lungpacer Medical Inc.
Greater Philadelphia
Overview
Work Experience
Chief Operating Officer
2023 - Current
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.
Vice President Operations
2018 - 2023
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. Concept development, applied research, design, product development, system engineering and project management. 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 the development of requirements and execution of resource allocation, plans and schedules. Responsible for the functional management of engineers, technicians and managers to help meet product schedules or resolve technical/operational issues. Responsible for managing company Intellectual Property.
Director of Catheter Product Development/Sr. Director Of Operations
2014 - 2017
Responsible for the management and leadership of all phases of design and development of disposable trans-vascular diaphragm pacing catheter 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.
Product Manager, Catheter
2011 - 2014
Providing design and technical expertise in the product development activities of disposable Trans-vascular diaphragm pacing catheter. Managing a team of engineers and Co-ops.
R&D Consultant
2011 - 2011
Advise and directly participate in the product development activities of existing and new products (Cardiovascular stents). Building a team of engineers for the development and implementation of engineering projects. Providing design and technical expertise in area of assigned development activities. Creating and Maintaining Company SOP’s. Reviewing procedures to ensure adequacy for device development to conform to business and Quality System requirements. Conducting training on Quality Systems, Statistical Techniques, and Design Techniques.
Mechanical Engineer
2007 - 2010
Managing projects, in the R&D phase as a part of a cross-functional team, from conception to production-level design of novel Intra Vascular Patient Temperature Management System. Managing projects in cost reduction initiatives for an acquired product line. Identifying and implementing design verification and validation test requirements, including the development of test plans, test protocols, and test reports. Executing testing as required, including the design and development of test fixtures and resources necessary to perform these tasks. Building and evaluating prototypes and design tools, as necessary, to test and refine product designs.
R&D Engineer
2006 - 2007
Handling design and development of Intra Vascular Patient Temperature Management System. Providing design and technical expertise in area of assigned development activities. Identifying and implementing design requirements including development of technical specifications, performance specifications, conformance to applicable standards, and product documentation in accordance with Company SOPs. Defining objectives, technical risks and options, and executing the design and development tasks in support of product development objectives. Identifying and implementing design verification and validation test requirements, including the development of test plans, test protocols, and test reports. Executing testing as required, including the design and development of test fixtures and resources necessary to perform these tasks. Building and evaluating prototypes and design tools, as necessary, to test and refine product designs. Participating in vendor qualification and vendor audits, as necessary.
Mechanical Engineer
2004 - 2006
Design and development of computer assisted tissue stapling and cutting devices in two different configurations. Organizing highly complex activities for the development and implementation of engineering projects. Conducting tolerance studies and applying geometric dimensioning and tolerance. Troubleshooting and following through with problem resolution.
Research Assistant
2002 - 2004
Developed a Simulator for Bone Drilling. The system provided high-fidelity dynamic graphic displays with a realistic force feedback during the simulated bone drilling operation. Designed and conducted experiments for measurement of drilling force on bones. Developed a mathematical model to calculate drilling force based on the drill geometry and cutting parameters. Designing necessary fixtures. Writing C++ codes for image segmentation of CT scans. Writing C++ codes for generating 3D models of bone from CT scans.