HARESH SHAH

Email: ac8pxc@r.postjobfree.com

SUMMARY

System engineer with 10+ years solid experience in system’s Hardware, Software, firmware, validation, Automated / Manual testing, Verifications for medical device, Network based Raid Storage, Client – Server Networking, System integration & Performance, Fault / Risk analysis, Team lead / player, Result Driven, Problem resolution and written communication.

Skills

IEC 62304:2006/2015 Medical device software life cycle

IEC 60601-1, 1-2, 1-6, 4-2, 4-3, 4-8 Basic safety and Essential performances for medical Electrical equipment

ISO 13485:2003 Quality management system for medical device

ISO 14971:2003 Risk management to Medical devices

Develop Test plans for software test case, Test Execution, Test report, Problem Report in Data base.

Validation of Portable device, GUI, UPS, Power supply, battery backup, Wi-Fi, Bluetooth, Barcode, Firmware update Test cases, Automated robotics system validation.

Statistical data analysis using Minitab, Excel

Developed SWV/IP/OQ/PQ protocols for R & D & manufacturing instruments for medical devices.

Win-XP, Seven, 2003, 2008, QNX, Linux, Solaris, Word, Excel, Visio, Power Point, MathCad, Lab view, Six sigma

Ran Automated / Manual test scripts, Developing/Modifying test scripts using C, Perls, Pythons, TCL, and Ruby.

GUI Application validation test for system using Test Quest Pro, QTP / Perl / Shell scripts.

Black box, Gray, White box testing for I/O devices, HBA, Controller IC, Network storage devices, and Medical devices & Aircraft industry.

Computer Interface – Wi-Fi, TCP/IP, FC, iSCSI, SAS, SATA, PCI-E, PCI-X, ADI, I2C, RS232, SCSI, USB

Window/Linux installation, configuration & Administration. Client/Server configuration & testing

Performance – Perfmon, Jet Stress, IOMETER, DT, HDD Tech, WinBench, TrendCom, SQLIO, Exchange I/O

Test tools – SCSI bus Host/target emulator, Logic analyzer, Audio meter, Volt meter, Oscilloscope, Network analyzer, Target simulators.

Storage / network configuration/Installation – Network Hub, Router, bridges, TCP/IP, VLAN, DHCP, DNS, Blue Tooth

Battery shelf life, EMI, Vibration, Temp, Power compliance requirements for RTCA/DO-160F requirements testing

PROFESSIONAL EXPERIENCE

Edward Life Science, Irvine, CA

Software Quality Engineer (Part time Contract engineer) 05/17 – 12/18

Involved in Software/Hardware Quality activity for software/Hardware development which include Multi-Shot Suture fastener device (Class II) which is used in Heart Valve implantation.

Review & update the Control board specification (SRS) for hardware & software requirements.

Review & negotiate the Hardware / Software validation test plan (SVVP) with third party contract manufacturer –Flex & Promenade Software.

Review & approve Software Unit test plan for white box testing.

Review & revise Software Risk hazard document (SHA).

Develop test protocol for Battery shelf life – 1 year requirements & interact with third party for test results report.

Review & analyze test data for device failure analysis. Involved in investigation with hardware/software development team. Run statistical analysis using Minitab, Excel etc.

Involved in IEC Standards - IEC 60601-1: 2005, Basic Safety, 60601-1-2 :2014 EMC, and IEC 60601-1-6: 2010 Usability certification

Involved in IEC 62304:2006 + AMD 2015 - Medical Device Software – Software Life-cycle Processes for compliance of software development process.

Fresenius Medical Care, Irvine, CA

Software Validation Engineer (Contract engineer) 03/16 – 3/17

Develop the Software validation IQ / OQ protocols for User interface library tool (UICAT) which is used in User Interface (UIC) application which was developed in Ruby, Android platform. Perform IQ/OQ validation activity & prepare software validation report.

Develop validation protocols IQ/OQ for VPAK software tool which was used for real time monitoring of Dialysis system operation. Executed protocols & prepare validation reports. Release all document in agile database.

Involved in various test protocols to validate Dialysis system for hardware / software release. Also update protocols for defects resolution, software changes, hardware upgrades.

Involved in updating Dialysis system firmware for each FPGA device. Report system issues via creating new SCR. Also involved in verification of SCR resolution.

Involved with manufacturing & hardware development group for system issues related hardware & verify system issues after resolved.

Involved in system performance measurements for benchmark performance for pumps, valves, sensors, Fluid Flow study. Use Minitab, Excel for evaluations of performance.

Used Jira project tools for work assignment reports, defects posting & updated.

Midmark Diagnostic, Torrance, CA

Software Validation Engineer (Contract engineer) 01/15 – 2/16

Develop the Software Engineering specification, Software test plan, Software validation protocols for the patient data Acquisition devices like SPO2/BP/Temp/Weight/ECG etc. & saved the report to Midmark/EMR database which includes Win 2008, 7.0, 8.0, 8.1, MS SQL server 2012, Internet explorer – 9.0/10.0/11.0 etc.

Developed the automated test scripts on test complete to verify GUI screens on Window server application.

Ran & report the test cases & generate the test report. Create bugs report into Microsoft Team foundation Server.

Study statistical process control for Everest patient monitor system for BP/Temp/Vitals data.

Use MS SQL database query to validate the patient record stored & read by user.

Used MS Word, Excel, Visio, Adobe Acrobat Pro Editor, Snag it, MS picture manager for protocols documentations.

Glidewell Dental Lab, Irvine, CA

Software Validation Engineer (Contract engineer) 06/14 - 01/15

Develop the Software validation protocols (PQ) & Software validation test scripts for the Low cost 3-D bench scanner which include TCP/IP, 3-D scanning camera, Servo control system, HTML files, Cloud storage interface for data files etc.

Assess the checklist for 21 CFR parts 11 for low cost bench scanner product.

Develop the Failure mode and Effects analysis (FMEA) for software validation protocol.

Developed the test scripts & test plan for network operation protocols. Ran & submit test report.

Ran & report the test cases & generate the test report. Create bugs report into Target process database tools.

Used MS Word, Excel, Visio, Adobe Acrobat Pro Editor, Snag it, MS picture manager for protocols documentations.

Use 3D application – Geomagic Gelios 2012 & Flexscan applications for unit level testing & validation.

Worked with QA dept for submitting SV protocols & test reports.

Biosense Webster (Division of JNJ) 02/13 – 02/14

Validation Engineer II (Contract Engineer)

Develop the Software Protocols (PQ) & Software validation test scripts for various instruments – UB25, Adhesive dispenser, Temperature Control ovens using PLC, & Cool flow pump, Data Acquisitions Instruments etc.

Develop the Installation Protocols (IQ / OQ/PQ) for various manufacturing instruments – Variac with Heat gun, Adhesive dispenser, burnishing tools which used in production of Renal Ablation catheters.

Developed MOP, ERP, PI procedure documents for manufacturing process validation.

Perform safety hazard analysis for software & hardware units. Perform & prepare report for EHS for electrical equipments.

Ran statistical analysis for Cp, CPK, Mean, STD parameters using Excel & Minitab for various bond joints study for aging protocols for renal catheter.

Use tools – Word 2007, Excel 2007, Minitab, cPDM database, Documentation, Photoshop, Multimeter, Temperature meter, Photo meter, Six Sigma etc.

Ran the test scripts & prepare the test report for software & Installation protocols.

Prepare SVW, IQ, PQ protocol test report & get approved with BWI Quality system.

Kontron America Corp 08/12 – 12/12

Software Test Engineer (Contract Engineer)

Develop the Test plan for touch panel interactive 2D/3D display unit (BCDU) which includes Wi-Fi, Ethernet, HDMI, LVDS, USB, RS-485, SSD, CPU, RAM, GPU subsystem hardware / firmware validation for unit / system level testing with Black box / Gray box test method.

Develop the operation Test procedure (OTP) for BCDU unit qualification test plan.

Involved in EMI, Vibration, Temp, Power requirements for RTCA/DO-160F requirements for BCDU.

Update the BCDU unit’s System Control Design (SCD) specification document.

Ran reliability & performance test on unit level validation of BCDU subsystem using Passmark, IOMETER, IPERF, tools for CPU, RAM, SSD disk, GPU, USB ports, ACPI requirements.

Ran the test cases for 2D/3D display unit test for LCD touch screen monitor, Magnetic card Reader, Camera, 3-D orientation, Audio/Microphone input/output, Fan, USB 2.0 ports, RS-485 bus.

Configure & ran test case for Ethernet & Wi-Fi network for BCDU unit under Window 7 O/S.

Track open bugs vigorously with development team & verify after issues resolved.

Installation & upgrade of Bios, drivers & Window 7 Embedded O/S, Operational Test software (OTP) for BCDU unit.

GenProbe Corp 10/11 – 08/12

Software Test Engineer (Contract Engineer)

Develop the Test plan for firmware validation of Automated Panther system which includes - MS SQL database, GUI, RS232, TCP/IP, UPS, Robotic Automation, Remote monitoring, Chemistry simulation.

Develop & execute test case for GUI interface, language translations, UPS, Barcode, Robotic movements, LIS simulator interface, MS-SQL Data base interface validation, Hardware fault injections etc.

Update the test cases as per SDS requirements. Execute the test case. Collect results after test case pass/fail. Post complaints in MKS database. Update HP Quality Center for validation results.

Resolved the open customer complaints & software open issues.

Track open bugs vigorously with development team & verify after issues resolved.

Firmware & Hardware installation & upgrade. Diagnose system with field supported test tools.

Familiar with HP Quality center, MKS / MS-SQL database, Word, Excel, Power Points.

Familiar with regulation of software standard for medical devices – 21CFR807, 21CFR814, 21CFR820, Quality standards

NexSan Corp 03/11 – 09/11

Sr. Test Engineer (Contract Engineer)

Develop the Test plan for firmware validation of Fiber channel, SAS & iSCSI storage controller which includes E18, E60 + E60x systems.

Installation of Server –Win 2008, 2003 & Linux O/S & configure 8GB FC, 6GB SAS, 10 GB iSCSI HBA.

Configure FC network using FC Switch, zoning & ran failover/Fail back test cases, fault injections, Remote boot etc.

Ran Performance benchmark for SSD, SAS & Sata drives, Drive qualification, Environmental, Shock, power pre-qualification & prepared test report.

Ran automated test scripts using PHP to configure the system for maximum Configuration.

Use test tools – IOMETER, IOZone, System debugger, system Performance.

Ran manual & automated test case & post problems in Census database.

Track open bugs vigorously & verify after issues resolved.

Masimo Corp 07/10 – 02/11

Validation Test Engineer (Contract Engineer)

Develop the Test plan for Communication test scripts which include verification of ASCII-1, ASCII-2, Blue Tooth test protocols for Radical 7C+.

Verify the Failure error codes of the products using simulated test setup – Voltmeter, Scopes, Wave form measurement, PC tools to capture data.

Developed the GUI validation test plan for the Radical 7C+ touch panel & keypad button interface.

Developed & ran manual test scripts for Battery backup, Touch calibration, Audio output, Docking station, ASCII 1 & 2 protocols

Ran automated test scripts & modify & debug TCL scripts for configuration change.

Report the firmware bugs in the Radzilla database & verified after Bug fixed in database.

Verbal & written communication skills with developers, Field Eng. & Marketing Pre-Sale support.

Analysis the output data errors using SPC, Excel & MathCAD tools.

Compare the instruments accuracy error using Statistical method.

Reviewed the high level requirements and test cases updated for Specification change requirements.

Peer Review the Test cases, Test plans, High level / Detail requirements.

Familiar with regulation of software standard for medical devices – FDA 510K, IEC 60601, 21CFR807, 21CFR814, 21CFR820, ISO Quality standards.

Prepare Test Report, DRO, Document release, Product manual review etc.

BioSense Webster / JNJ 12/09 – 06/10

Validation Test Engineer (Contract Engineer)

Ran the Automated test scripts using Test Quest Pro, C, Emulator & debugging.

Developed the GUI validation test plan for the SmartAblater / Stockert 70 system.

Developed & ran manual test scripts for GUI user interface, Audio, Temp. Output validation.

Report the firmware bugs in the database & verified after fix done.

Involved in white box testing Emulator verification for WinCE base based system.

Wrote the Use Cases & test cases to include various medical devices - Catheters, Fluid pump, Recording system, Carto-3/ Carto XP Mapping systems, Esophageal probes etc.

Maintain the high level requirements, Detail requirements, Use Cases and test cases in VMT database.

Peer Review the Test cases, Test plans, High level / Detail requirements.

Familiar with regulation of software standard for medical devices – 21CFR807, 21CFR814, 21CFR820, Quality standards.

Used Word, Excel, VMT, cPDM database tools to developed test cases & use cases.

iStor Network Inc. 04/07 – 11/08

Sr. Test Engineer

Ran Automated / Manual test scripts for firmware / hardware validation. Modified Perl & Python scripts.

Involved in Java based GUI application verification using Quick Test Pro

Developed the test plan for the iSCSI firmware testing for network based storage controller

Setup & ran Network storage configuration using TCP/IP, Routers, VLAN, iSCSI protocols

Developed test cases to verify various OEM customer configurations.

Verification with Microsoft HCT and WHQL compliance requirements for network storage device.

Execute the test cases and report results and problems in MySQL defect tracking database. Follows the open issues vigorously.

Worked on board level testing, Power supply, Internal / External electrical interface, Battery backup, Enclosure services for SAS/SATA.

Involved in Unit level /Functional / System level testing at EVT / DVT software development cycle.

Involved in Performance, Stress testing - Exchange I/O, IOMeter, DiskTest, Diskload, SQLIO

Used various test tools – Network, SAS/SATA analyzer, Voltmeter, Oscilloscope.

Intralase Corp. 06/06 – 01/07

Software Test Engineer (Contract Engineer)

Involved in firmware Change verification, C & C++ code review

Support the test scripts for the installation, upgrade of new software releases for QNX O/S.

Developed the test protocols for Unit, system and GUI level for Medical device – LASIK surgical system.

Involved in System specification, Design & Validations documents for the 510K pre-submission.

Familiar with regulation of software standard for medical devices – 21CFR807, 21CFR814 & 21CFR820

Familiar with Software Risk & Safety Hazard analysis, Software Quality model

Supported Software Change Control management process using ClearQuest Management tools

Involved in GUI test to verify Use errors & Human factors

Supported Electrical hardware change control and verification of electronics devices – CPU, A/D, D/A, Motor, Power supply, Laser, Audio.

Involved in statistical analysis of clinical test data to support system reliability & performance.

Quantum Corp. 03/05 to 5/06

Sr. Test Engineer (Contract Engineer)

Involved in FC based device – Raid, Tape drives, autoloader device testing under SAN storage networks

Firmware validation of SCSI / FC / ISCSI based storage devices under Win2k3, Win-XP & Linux O/S.

Used SCSI/FC/Network analyzer and test tools for debugging firmware of autoloader and tape devises.

Conducted fault injection test to verify the system errors and recovery methods.

Ran Automated / Manual test scripts to verify the system reliability

System level testing using Tape backup/restore data for the network based system-using legato, Veritas application

Developed test plan and test cases for firmware validation of the OEM customer – IBM, Dell, Sun, HP.

Report the product failure problems using the Clear Case tools.

Collect the system faults log and analyzed the root cause problem. Accelerate the problem resolution with the design team.

Analyses the Electrical hardware failure in automated tape library & report problem to design team.

Lead the small test team for the firmware/hardware release for Elgato tape library.

INTEL Corp 3/04 to 2/05

Validation Engineer (Contract Engineer)

Developed the test plan and collect software test cases to validate the third party RAID firmware stacks.

Defined the hardware test plan and validate the Intel controller chipsets (PCI-E to SAS/SATA) using Black box testing.

Used various hardware diagnostic tools – Red boot, HSD, JTAG, and SAS/SATA analyzer.

Developed the software test plan to validate device driver for the SAS/SATA I/O controller for Dell/Intel/HP system.

Define the test strategy for RAID firmware stack developed by OEM – LSI, Emulex, and Adaptec.

Document the open problem issues & worked with software/hardware design teams for resolutions.

Involved in writing and modifying test scripts written in Window and Linux O/S.

Install, configure & validate network & storage drivers.

Communicated with different teams for the product specification, test plan and schedules.

Unisys Corporation, Mission Viejo, CA 05/87 – 02/03

System Hardware Engineer

Developed the diagnostic test program using C, C++ for disk and tape devices for system reliability.

Validation of firmware and drivers for storage adapters and device – disk, tape drives, tape library under SCSI, Fiber Channel, IDE, Serial ATA, TCP/IP, iSCSI bus.

Test tools used – Oscilloscope, SCSI/FC/ Network analyzer, Test scripts, TCK, Algol, VB Scripts

Software qualification of applications - Storage Sentinel, Tape backup/restore on Win2k and win2K3 O/S

Testing & qualification of network HBA - Intel, Adaptec, Broadcom & Myrinet, using hubs and routers

Involved in the system and adapters design verification, failure analysis and reliability.

Integration, qualification of Network attached storage file server.

Developed test plan to validate drivers, firmware, adapters under Window and Unix O/S.

Involved in storage subsystem qualification for Environmental, Power, Vibration, EMI compliances test.

Collected and analyze failure data for the test case. Problem logged in Unisys Defect tracking tools.

Provided written communication to vendors and customers for product’s problems and resolutions.

EDUCATION

M.S. Computer Science New York Institute of Technology, New York, 1986

M.S. Electrical Engineer University of Bridgeport, Bridgeport, CT, 1977

B.Sc. Physics/Math Gujarat University, Ahmadabad, India, 1971

Personnel: U.S. Citizen

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