Prasenjit Das

Experience

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  Larsen & Toubro Limited

  Jan 2007 - Jan 2013

  Project Lead for New Product Group, AVS, Six Sigma Green Belt, SAP interface between ABAP-er and user Production Management, Planning, Assembly Line Setup, New Product Productionization, Quality Audit requirement maintenance, MRP, Six Sigma, VE Manufacturing Lead for Patient Monitoring SystemsProject Lead for Design and Development of Anesthesia workstation

  • Assistant Manager

    Aug 2011 - Jan 2013

  • Senior Executive Engineer

    Sept 2008 - Jul 2011

  • Sr. Executive Engineer

    Sept 2008 - Jul 2011

  • Sr. Engineer

    Jan 2007 - Jan 2011
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  Skanray Healthcare

  Jan 2013 - Mar 2014

  Assistant Manager
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  Skanray Technologies

  Apr 2014 - Jul 2015

  Assistant Manager

  Project and Quality Lead in Design Department for Anesthesia Workstation development. Responsible for compliance of design with IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 62304, Design norms as per ISO 13485 and Risk Management as per ISO 14971, IEC 60601-2-12 and IEC 60601-2-13. Trainer to sales/service team on product and ISO norms. Responsible for product quality during manufacturing as well as post-sales. Owner for all failure resolutions. Work with and guide verification/validation teams for product performance and quality evaluation and establishment. Supervise SDLC management and FDA 510k documentation.Work closely with Regulatory Engineers to supervise TRF fill-up and submission, handle all queries by Notified Bodies, Hazard reporting and resolution. Responsible for maintenance of QMS and represent section in QMSR. Auditee to ISO audits and FDA inspections. Show less

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  Skanray Technologies Pvt. Ltd.

  Aug 2015 - Dec 2018

  Manager

  Responsible for Respiratory Management Products (Anesthesia Workstation and ICU Ventilators) and Surgical Diathermy products. Operating as Business Unit Head repoting to Managing Director. Responsible for Internal Quality, Manufacturing Output and Design projects. Continued to be responsible for compliance of design with IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 62304, Design norms as per ISO 13485 and Risk Management as per ISO 14971, IEC 60601-2-12 and IEC 60601-2-13. Trainer to sales/service team on product and ISO norms. Responsible for product quality during manufacturing as well as post-sales. Owner for all failure resolutions. Work closely with Regulatory Engineers to supervise TRF fill-up and submission, handle all queries by Notified Bodies, Hazard reporting and resolution. Responsible for maintenance of QMS and represent section in QMSR. Supervise SDLC management and FDA 510k documentation. Train the team globally for continuous knowledge improvement Show less

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  Baxter International Inc.

  Jan 2019 - Sept 2024

  Lead System Integrator, Project management, Technology transfer, Work Stream coordinator for Renal PD projects

  • Program Manager

    Oct 2021 - Sept 2024

  • Project Leader II

    Sept 2019 - Sept 2021

  • Lead System Integrator

    Jan 2019 - Aug 2019
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  Quest Global

  Sept 2024 - now

  Program Manager

  Program Manager in Healthcare vertical for Quest Global Engineering Services Bangalore. Owner of partnership with GEHC and leader of teams in GEHC Business Unit for all planning, execution and performance assurance.