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PROJECT LEAD
Profile

7.2 years of Experience Hardware Design and involved in complete hardware Life cycle from idea generation, Design Implementation, prototyping, production to product supporting and Sustenance for Medical and Industrial Domain

Skills

•Hands on experience Design of Analog and digital based circuit design

•Experience in 8 bit ,16 bit ,32 bit processor/ controller based design, FLASH, SDRAM, EEPROM memory interfacings,

•Proficient in Component selection, BOM Creation, Circuit analysis, Schematic design, PCB Review, Timing analysis and FMEA, ROHS analysis, Tin Wishers analysis.

•Have hands on experience in various testing Board Bring Up, Environmental testing ,HALT, Random Vibration and shock testing, design verification testing, component life cycle testing.

•Experience in I2C, SPI, USB2.0, 3.0 based circuit design.

•Familiar with wireless module interfaces like Wi-Fi module, Bluetooth modules, RF module, LCD ADC Interfaces and Regulator, LDO,MOSFET, IGBT and IPM based power design Interfaces.

•Good Understanding of standards IEC 60601-1, IEC 60601-1-8, IEC 60601-1-24,UL 94, UL1093 and regulatory assessments like 21 CFR part 11 and 21 CFR 820.Field Failure Analysis.

•Extensive knowledge in Equipment Validation (IO, OQ, PQ), Hardware verification, Test Method validation, Requirement creation and feasibility studies, Re-design and Reverse Engineering.

•Experienced Validation of Test Methods: Inspections, Compendia, Variable and Attribute. R&R Analysis.

•Good knowledge in Configuration Management, Onsite and Offshore Team Coordination

•Experience in project management activates like Team Status Tracking, WSR presentation with client, MOM capturing, Third party Vendor and Manufacturing facility coordination.

•Experience in Resource allocation, MOM preparation, Design transfer co-ordination between R&D and manufacturing facility, vendor relationship.

•Hands on experience in Lab equipment's like Multi meter, Digital Oscilloscope, Function generators, Current probes, logical analyzer, ESD charge pumps, Impulse generators, HT cable testers.

Accomplishments
  • Design universal digital GATE Wiki powered by solar cell and Wind Mill (Academic project) Tools used: Bread Board and logical gate ICs Description: This is one of the good projects developed for my college Digital electronics lab.
  • The intent of the project is understand the full basic digital logics and digital circuit design, that is a picky pack model so that anyone can easily build their own digital circuit also understand the full logical combination based on the LED output.
  • Power delivering to this device is a solar panel with automatic panel positing changing based on the LDR control and 12VDC from Wind Mill.
  • This is not a commercial project but this is intended to give train all of my juniors in my college.
  • Roles and Responsibilities: Full Circuit designed for documentation using Multisim Soldering and component selection Panel motor control circuit design based on the feedback from LDR Switching circuit and over voltage and over current protection for solar and Wind Mill power Power budget analysis Wind turbine direction control electro mechanical design 1.
Professional Experience
Project LeadMay 2013 to Jul 2015
HCL America Inc
  • Re Design of Infusion Pump (Volumetric).
  • Tools used: Allegro PCB design, Titan Test Tool, Cam 350 and HP Quality Center 10.0.
  • Duration: 9 months Description: This project is updating and upgrading a product already exists in market.
  • It is a volumetric infusion pump, because of EOL Micro controller(32 bit ARM 9 Freescale controller) and Flash memory(128 MB NOR),SRAM(8 MB Cypress) and LCD got obsolete so replaced all with active components and some upgrades including some active sensors occlusion and Air in Line and smart battery.
  • Almost all major parts of the pump were updated with new parts with RoHS and REACH compliance.
  • Roles and Responsibilities: Full schematic upgrade from Orcad to Altium Designer Board bring-up and Acceptance test plan creation Component identification with RoHS and REACH compliance Risk Assessment and FMEA for EOL parts Like to Like analysis for identified and existing parts Power budget analysis for complete board Component placement and routing analysis Timing analysis for FLASH and SRAM with MC Test Feasibility study for Test fixture development Cross functional coordination for Flexible PBC design Updated the C code for changing pin configuration and LCD brightness and color adjustment Design verification testing under stress (+45 - room- -5 deg) temp Leakage test and patient leakage test as per IEC 60601-1 Sound level testing as per IEC 60601-1-8 Flow rate accuracy testing per IEC 60601-1-24 Summary report preparation for Regulatory submission Design of 2nd Gen Glucose level monitor (RF and BTLE) Tools used: Allegro PCB design, LTspice, Xilinx System Generator.
  • Description: The Design involves activities from concept creation to the final product (wearable device).
  • This project deals with the activities to be carried out on implantable RF transmitter collect the glucose level from human blood and transmit to external device with process the data and send to the mobile devices via Bluetooth communication.
  • MSP 430 used for processing the data and Bluetooth, RF module interfacing UART and I2C protocol used, MP39C504 used for power management.
  • Roles and Responsibilities: Baseline Idea creation and Requirement Creation Power budget analysis.
  • Prototype design and testing.
  • Schematic design symbol creation and design review.
  • Simulating the data transfer System generator software used Component Selection Board bring up Testing protocol and Report creation Test method validation Prepared documents for Regulatory submission Low Cost board design Design Semi-automated pulse echo scanning velocity meter.
  • Tools used: Allegro PCB design, Multisim, HP Quality Center 10.0.
  • Description: This project designed for measuring and detecting the bone cracking and surgical implants cracks.
  • This is a semi-automatic method of finding the cracks in the implants and human bones, pulse echo method used to identify the time taken for echo travel(t1) and repels(t2) then the data captured and analyzed(V=distance/t so (t1-t2)) by using Cortex-M4 processor.
  • A graphical LCD/OLED display used to display the echo waves.
  • Also this device used for measuring the physical and elastic properties of materials and drug purity.
  • Roles and Responsibilities: Ultrasonic sensor selection and tuning Prototype developing and testing Features implementing and idea creation Component selection and analysis RoHS, REACH and Material declaration identification Circuit simulation using multisim Full circuit Design using Altium Designer, bringup and PCB review Test case Preparation using HP Quality center 10.0 Technology proofing/demonstrating in different universities and industries End user feasibility study and update Custom design of circuit product shape for location constrains Vendor communication and cross-sectional team coordination Allegro PCB design, HP Quality Center 10.0, MiniTab Description: This project is addressing a 510K issue from Regulatory Body (FDA).
  • The product is a next generation advanced infusion pump with communication and central gridded drug library system.
  • Because of some false alarm and mal function FDA stopped production so analyzed the product and the manufacturing plant and identified the product and process flaw then fixed and supported until the product get released .This project had 3 phases a) Issue Fixing and updating b) Equipment Validation and Computer System Validation c) Test Method Validation Roles and Responsibilities: Issue Fixing and updating Schematic updated for EOL replacement using Altium designer Requirement analysis and identified the SAC requirement Technical review and creating change proposals for updated requirement All software and hardware protocols updated for updated requirement FMEA for the updated components and updated requirements Technical Review for all test protocol and SOP update Design verification testing Equipment Validation and Computer System Validation Validation plan and protocol preparation for the manufacturing equipment IQ, OQ, PQ test case prepared in HP quality center Quality and Regulatory assessment preparation based on 21 CFR part 11, 21 CFR part 820.
  • PQ build and sampling, testing Report preparation and CAPA supporting Test Method validation Analyzing and identifying the requirement.
  • Identifying the appropriate test method ( inspection , variable or attribute , Compendia) Validation protocol preparation Updating the existing protocol based on the identified test method R&R study and execution R&R analysis using Mini Tab application Report preparation Prepared summary reports for FDA submission Design Sustenance for Infusion pumps (Drug delivery Systems syringe andvolumetric pumps) Tools used: eCentral (PLM tool), Allegro PCB design, LTspice, Timing Designer.
  • Description: The Design Sustenance activity involves activities from concept creation to recycle of the released product.
  • This project deals with the activities to be carried out on class-3 medical device Defibrillators after the release of a product such as revision of the product, field failures fixing, Redesign of the Boards, RoHS risk analysis, RoHS replacement identification and qualification, Alternate manufacturer part identification, design changes and Life cycle database maintenance.
  • Roles and Responsibilities: Board redesigning Schematics symbol creation and modification Schematic and PCB update to implement the design change Creation electrical requirements specification, Electrical development plans Design analysis for redesigned boards.
  • Board bring up and trouble shooting.
  • PCBA component verification Component selection and qualification.
  • Determination of Part obsolescence and replacement RoHS component selection and qualification Per JEDEC and iNEMI standards Tin whisker and reflow assessments Tin whisker short Failure mode analysis and Mitigation Component FMECA Implementation of request for design changes(RDCs) and MOLs Create change request, Change orders, Drawings and MEPs Product Lifecycle Management database revision Design change to reduce cost Product change notification review and implementation.
  • Implement changes for performance enhancement Engineering Bill of materials change update and PCB/PCBA revisions PCB/PCBA manufacturing support Dfx reviews and support PCBA verification plan creation.
  • PCBA component verification report creation.
  • Create/revise/update design documents and release in client system per client's process.
  • Co-ordinate with offshore team on daily basis to avoid line down.
  • Supplier/manufacturer interaction for custom part changes.
  • Customer interaction for technical data and status reporting.
Lead EngineerOct 2013 to May 2013
HCL Technologies
Hardware EngineerJan 2010 to Oct 2010
Central Leather Research Institute － Chennai, India
Application Development EngineerMay 2008 to Jan 2008
Vi Microsystems Pvt Ltd － Chennai, India
Education and Training
Bachelor of Electrical, Electronics EngineeringExperience in I2C, SPI, USB2.0, 3.0 based circuit design. *Familiar with wireless module interfaces like Wi-Fi module, Bluetooth modules, RF module, LCD ADC Interfaces and Regulator, LDO,MOSFET, IGBT and IPM based power design Interfaces. *Good Understanding of standards IEC 60601-1, IEC 60601-1-8, IEC 60601-1-24,UL 94, UL1093 and regulatory assessments like 21 CFR part 11 and 21
Diploma, Electrical and Electronics EngineeringElectrical and Electronics Engineering
Diploma, Information System ManagementInformation System Management
Certifications
EDA Tools: Orcad, Altium Designer, Xilinx System Generator. *Test Management Tool: HP Quality Centre. *Configuration Management Tool: Serena Dimensions CM, TCU.
Skills
21 CFR part 11, budget analysis, C, circuit Design, color, hardware, concept, Configuration Management, controller, client, data transfer, database, delivery, LCD, Dimensions, Embedded C, Feasibility study, Features, Flash, functional, HP, inspection, IQ, market, materials, MB, memory, MiniTab, next, OQ, Orcad, PLM, PQ, proofing, proposals, protocols, Quality, reporting, Requirement, risk analysis, Risk Assessment, routing, scanning, Schematics, Simulation, SOP, Sound, specification, Statistical Analysis, t1, trouble shooting, t so, upgrades, upgrading, upgrade, USB2.0, Validation
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Resume Overview

Companies Worked For:

  • HCL America Inc
  • HCL Technologies
  • Central Leather Research Institute
  • Vi Microsystems Pvt Ltd

Job Titles Held:

  • Project Lead
  • Lead Engineer
  • Hardware Engineer
  • Application Development Engineer

Degrees

  • Bachelor of Electrical , Electronics Engineering
    Diploma , Electrical and Electronics Engineering
    Diploma , Information System Management

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