SUMMARY

• Over thirteen years of experience in the area of embedded software design and verification and validation, and five years of experience in project management.
• Solid management skills, demonstrated proficiency in leading and mentoring individuals to maximize the level of productivity while forming cohesive team environments in onsite/offshore execution models.
• Knowledgeable in the medical product design and development process, MQMS. Certified in ISO 13485. of attendance in 21 CFR Part 11.
• Proficient knowledge of SDLC Waterfall model and theoretical knowledge on agile methodology.
• Worked on design, development and integration at system, subsystem and component level embedded device. Design included multi - processor architecture boards.
• Worked on the product from software design, software/system verification, device verification automation framework and medical device risk management as per ISO14971:2012.
• Worked as a DOORS project administration from requirement development until Trace matrix analysis.
• Worked on Class III medical device SDLC and device risk management.
• Worked on design FMEA, performing FMEA, system FMEA, RACT and post marketed product analysis
• Understands the system requirements/ products specifications and preparation of system analysis reports and system design documents.
• Performed customer product awareness, including preparation of the material/user manual and provided on-site .
• Worked on project scheduling, design scope statements and the development and deployment process.

TECHNICAL SKILLS

Hardware: AT91SAM9263, National Semi-Geode Processor, 89C51RD2, PIC 16 Series, NI cFP-2000, NI PXI Configurable Chassis

Languages: C, C++, Java, VBScript, LabWindows CVI, LabVIEW and LabVIEW RT

Operating System: uCOS-II, SMX, Linux

GUI/TOOLS: AWT, Swing, Docklight, Mercury Quality Center, QAC++, Source Insight, BPLM, Team Center Unified, Bender RBT.

IDEs Used: Code Warrior, IAR Embedded Workbench, KEIL and WinIDEA, Delphi

Project Management: PMSmart, MS Project, Prime, SharePoint

Version Management: PVCS, Clear Case, Serena Dimensions

Defect Trackers: Clear Quest, PVCS Tracker, JIRA

Requirement Mgmt.: DOORS - IBM

Scripting Tools: DXL, VB Script, JavaScript, XML, Perl

PROFESSIONAL EXPERIENCE

System Engineer

Confidential, RoundLake, IL

Responsibilities:

• Involved in requirement analysis and reviewed the requirements for its completeness.
• Analyzed interface with cloud based platform.
• Developed and validated the DXL scripts to support the product development tracking and risk and hazard analysis database population.
• Developed product and component risk assessments.
• Labelled verifications and material preparation.
• Designed history file creation for all of the components and disposables.
• Developed device service and calibration software.
• Coordinated and reviewed the products progress and participated in status calls with clients and offshore.
• Responsible for product sustenance change package support, NCs and CAPA.
• Provided service document updates as per remediation.
• Risk files review and remediation as per corporate procedures.
• Developed the sub-systems, system and language verification related to the test cases, reviews, executions and IR creation.
• Requirement and bender pair wise test case scenarios and test design.
• Developed the device test automation framework.
• Test step up configuration tracking and management.

Environment: C, C++, IBM DOORS, XML, DOM, Clear Case, Clear Quest, Serena Dimensions, JIRA, QTP, Quality Center, Vector Cast, VB Script, LabVIEW RT, Bender RBT, Team Center Unified, Track wise 8, PMSmart, MS Project, 8051 Hardware Emulators, NI PXI Chassis, ISO 1, MQMS-ISO13485.

Software Lead

Confidential

Responsibilities:

• Developed system requirement and gap analysis.
• Developed functional testing software using LabVIEW.
• Unit testing and code coverage.
• Developed integration test protocols.
• Execution of the test protocols and test execution coordination.
• Reviewed the test protocols.
• Defect identification and logging.
• Defect fixing and regression verification.

Environment: LabVIEW, NI PCI Cards, PVCS, Serena Dimensions.

Software Lead

Confidential

Responsibilities:

• Analyzed software requirement and gap analysis.
• Played a major role in implementing the therapy software as per SDLC.
• Unit testing and code coverage.
• Reviewed the integration test protocols.
• Reviewed the test protocols.
• Executed the software test protocols and test execution coordination.
• Defect identification, logging and part of a review board.
• Defect fixing and verification of software after the defect fix.
• Developed the simulator which is used in software verification using LabVIEW

Environment: C, C++, Rational DOORS, PVCS, Serena Dimensions, QAC++, LabVIEW, SMX, AT91SAM9263, Doc light, Source Insight, Code Warrior, IAR Embedded Workbench

Software Lead

Confidential

Responsibilities:

• Analyzed software requirement and gap analysis.
• Played a major role in implementing the therapy software as per SDLC.
• Unit testing and code coverage.
• Reviewed of Integration test protocols.
• Reviewed the test protocols.
• Executed the software test protocols and test execution coordination.
• Defect identification, logging and part of the review board.
• Defect fixing and verification of software after the defect fix.
• Developed a simulator which is used in software verification using LabVIEW

Environment: C, JAVA, Linux, PVCS, Serena Dimensions, QAC, McCabe, LabVIEW, National Geode Processor.

Software Engineer

Confidential

Responsibilities:

• Requirement development and analysis.
• Developed rapid prototypes using the system NI CFP-2000 and LabVIEW.
• Designed and developed the real system using the low cost hardware Rabbit BL2120 with uCOS-II.
• Developed software for the control system.
• Developed integration and system test cases.
• Participated in field approval with RDSO.

Environment: C, uCOS-II, NI CFP-2000, LabVIEW, LabWindows, Rabbit BL2120, KEIL, Dynamic C.

Software Engineer

Confidential

Responsibilities:

• Requirement development and analysis.
• Designed microcontroller based hardware boards.
• Developed software for the system.
• Developed unit and system test cases.
• Participated in user acceptance approval testing.

Environment: C, KEIL, 8051 series microcontroller Hardware.