Komal Vyas Dholakia Email and Phone Number
7+ years of rich experience in growing medical device manufacturing industry.
Artem Healthtech Pvt. Ltd. (Formerly Known As Express Diagnostics Pvt. Ltd.)
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Lead Product EngineerArtem Healthtech Pvt. Ltd. (Formerly Known As Express Diagnostics Pvt. Ltd.) Apr 2023 - PresentAhmedabad, Gujarat, India- Knowledge of ISO 13485 - Quality Management System for Medical Device System- Knowledge of IEC standards related to Medical Devices (e.g. IEC 60601-1, IEC 60601-2-25, IEC 60601- 1-2)- Knowledge of ISO 14971 - Risk Management for Medical Devices- Actively working in product delivery, overseeing QC and Production departments.- Development of high-quality product design- Requirement gathering and feature impact analysis.- Troubleshooting issues and improvement in product performance.- Oversee and manage product manufacturing process.- Analyze and implement the changes.- Risk mitigation and reporting ahead of product finalization.- R & D of various Medical Devices.- Algorithm development for various Devices.- Testing Workflow and output of Medical Devices.- Manage Device testing before dispatch.- Inventory Management.- Interpret and implement regulations and standards (e.g., FDA, ISO) to ensure product compliance.- Prepare and maintain regulatory documentation, including submissions, reports, and technical files.- Assess and manage risks associated with product development and regulatory compliance.- Collaborate with quality assurance teams to maintain high standards of product quality and safety. -
Lead Product EngineerHospisoft Pvt. Ltd. Apr 2022 - Apr 2023Ahmedabad, Gujarat, India- Development of high-quality product design- Management of POCs & Demos- Development, implementation, and CS team management- Define and improve process- Workflow management- Requirement gathering and feature impact analysis- Troubleshooting issues and improvement in product performance- Coordination with product development team- Oversee and contribute to product manufacturing process- Analyze and implement the changes- Risk mitigation and reporting ahead of product finalization- Release management -
System Integration EngineerHospisoft Pvt. Ltd. Jun 2016 - Mar 2022Ahmedabad Area, India- R & D of various Medical Devices- Algorithm development for various Devices.- Manage Product development based on requirements- Testing Workflow and output of Medical Devices- Manage Device testing before dispatch- Worked on development of Wi-Fi ECG device for the remote patient monitoring system- IOT technology is used for the data communication between the ECG device and patient monitoring computer- Touch screen LCD programming using Arduino board for this device- Interfacing ECG device with Wi-Fi and touch screen LCD- Worked on development of digital X-ray film processing- Made GUI in python for radiology image processing -
Embedded EngineerArchana Automation Limited Jun 2015 - May 2016Junagadh Area, India- Working on the project of video capturing- Make reports and BOM(Bill Of Material) for projects- Making Schematic design for the circuit (DXP Portel – Altera)- Making GUI (Graphical User Interface) in MATLAB
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Teaching AssistantNirma Institute Of Technology Jul 2014 - Jun 2015Ahmedabad Area, India- Guide students in their Lab sessions - Assist faculties in their research and academic work
Komal Vyas Dholakia Education Details
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Nirma Institute Of TechnologyElectrical, Electronics And Communications Engineering -
Ganpat UniversityElectronics And Communications Engineering
Frequently Asked Questions about Komal Vyas Dholakia
What company does Komal Vyas Dholakia work for?
Komal Vyas Dholakia works for Artem Healthtech Pvt. Ltd. (Formerly Known As Express Diagnostics Pvt. Ltd.)
What is Komal Vyas Dholakia's role at the current company?
Komal Vyas Dholakia's current role is Lead Product Engineer.
What schools did Komal Vyas Dholakia attend?
Komal Vyas Dholakia attended Nirma Institute Of Technology, Ganpat University.
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