Krishanu Das Email & Phone Number

Redwood City, Ca, Us

New Brunswick, New Jersey, Us

New Brunswick, New Jersey, Us

New Brunswick, New Jersey, Us

Foxborough, Massachusetts, Us

Led a $1.4 million NPI project for setting up a catheter manufacturing product line in an ISO class 7 cleanroom.Led a team of two manufacturing engineers, one quality engineer and two engineering interns towards launching the catheter product line.Responsible for purchasing and installing equipment’s costing a total of ~$800, 000 to set up the catheter product line.Identified gaps and risks to project completion and drove mitigation plans.Developed the RC Catheter product line validation strategies and authored respective Master Validation Plans.Authored 11 protocols, 4 routers, 15 work instructions and 10 equipment operating instruction documents.Conducted Installation, Operational and Performance Qualifications on new equipment’s and processes.Conducted risk analysis of processes and created strategies to mitigate potential risks.Assisted in the development of a ramp strategy and led execution of the ramp project plan for the catheter line to increase production to ~15,000 catheters / month and increase revenue by approximately $500,000 / month within the first 6 months to meet customer demand.Coordinated with cross functional teams (supply chain, operations and quality engineering & assurance) to ensure readiness for production volumes.

Warsaw, Indiana, Us

Manufacturing Lead on the Cycle Time Reduction projects for all final clean equipment (~3500 products), generated cost savings of ~$550,000 and reduction of cycle time by 150 seconds.Realigned manufacturing process of knee products to a single facility, resulted in reduction of manufacturing lead time by ~27%, scrap rate reduction between 6% – 9% and generated cost savings of ~$250,000.Provided recommendations to remediate deficiencies in manufacturing processes.Created a pipeline of future projects and validations to increase efficiency of final clean equipment.Successfully completed 13 validation projects of technically complex nature and executed 8 Operational Qualifications and 10 Performance Qualifications on various medical implants.Created 7 new ZWI's (Zimmer Work Instructions) used in two separate manufacturing facilities.Assisted in the development of the validation sampling plan Global Standard Operating Procedure (GSOP).Created and updated manufacturing procedures (routers and BOM’s) for new and legacy products.Performed statistical analysis using Minitab on validation data.Experienced authoring and executing Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) & Validation Summary Report (VSR).Experienced working on the Action Plan and Implementations phase of multiple CAPA projects.Determined fixture and tooling requirements for products.

Coordinated aspects of production, including selection of manufacturing methods & fabrication.Led the additive manufacturing process of creating 3D printed models of organs using a variety of materials (eg: PLA, Resin etc.)Responsible for business development and marketing strategy.Led the company to the 1ST50K startup competition finals as one of the 9 finalist chosen amongst 13 countries. https://www.codefiworks.com/blog/1st50k-announces-nine-finalists

Tampa, Florida, Us

Worked as a Product Owner for the development of the College of Nursing (CON) website and drove the project from the requirement gathering phase to the implementation process.Developed prototypes of websites using Axure Pro 7.0 for business clients.Assisted in the development of project scope and defining requirements at the biweekly scrum sprint planning meeting.Responsible for requirement management, simplification, communication and analysis using agile user stories.Act as a liaison between the client and the web development team.Assigning work to the web developers after understanding their level of expertise in Microsoft CMS, WordPress and Sitecore.Responsible for reviewing all the iterations made by the web development team before contacting the clients.

Tampa, Florida, Us

Responsible for creating and updating documentation on Patient Centric Information Systems (PCIS) application supported by USF Health IS.Documentation on PCIS created by testing software using VMware virtual machine.PCIS documents created consisted of financial specialist, transaction editing system (TES), claims resolution, scheduler, revenue cycle operations (RCO) and payment posting documents.Develop, maintain and publish drafts for standard operating procedures & review current computing standards and policies to suggest updates and changes.

Mumbai, Maharashtra, In

Worked alongside the sales team during sales pitch as the point technical person for medical devices (Defibrillators and Patient Monitors)Responsible for providing demonstrations of medical devices to doctors and nursing staff at hospitals.Responsible for installation and post sales maintenance of medical devices.Worked with over 40 doctors spanning over 8-10 major hospitals, ranging from cardiovascular surgeons to anesthesiologist’s providing demonstrations and installing the medical devices.Provided training to nursing staff on how to use the automatic external defibrillators (AED) devices at hospitals and nursing facilities.

Master’S Degree, Bioengineering And Biomedical Engineering

Bachelor Of Engineering (Beng), Biomedical/Medical Engineering