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Senior System Software Test Engineer Resume

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Dedham, MA

SUMMARY 

  • Experienced engineer in quality assurance ensuring accuracy of results in development Life Cycle.
  • Expert in exploratory analysis, traceability matrix for acceptance; knowledgeable in risk and CAPA.
  • Experienced with validation of SOP, test case, conditional analyses, boundary, stress and performance.
  • Experienced in design of Black - Box, White-Box, and Unit tests, verifying software’s functional paths.
  • Experienced with VM, Cloud technology, Web portals, medical instruments, software systems for security.

SKILLS:

  • Test Planning
  • Quality Assurance
  • Agile Scrum
  • SDLC
  • Waterfall
  • Integration
  • Performance
  • Cloud Computing
  • Medical Devices
  • XML
  • Software Engineering
  • V&V
  • Mobile Applications
  • Enterprise Security
  • PKI
  • Embedded Software
  • Simulation
  • Gaming
  • SolidWorks
  • Biotechnology
  • Visio
  • DOORS
  • Team Concert
  • Jazz
  • ClearQuest
  • Camstar
  • SpiraTest
  • OnTime
  • JIRA
  • TeamTrack
  • Subversion
  • PVCS
  • SharePoint
  • VMware
  • Firewall
  • Web Filters
  • AV
  • Failover
  • High Availability
  • Hypervisor
  • Blackberry
  • TCP/IP
  • VPN
  • PPTP
  • L2TP
  • IPsec
  • LIMS
  • HIS
  • ASTM
  • HL7
  • POCT1
  • Pairwise
  • XML
  • Ethereal
  • Wireshark
  • Fiddler
  • WinScp
  • SSH
  • Shell
  • WinCE
  • Windows server
  • Linux Red hat
  • Knowledge of: Visual Studio
  • pgAdmin
  • used PostgreSQL
  • C
  • C++
  • C#
  • FDA guideline QSR 21 CFR 820
  • 21 CFR part 11
  • ISO 13485
  • IEC 62304
  • ISO 9001.

EXPERIENCE

Confidential, Dedham, MA

Senior System Software Test Engineer

  • Completed and delivered 3 V&V Computer System Validation projects for number of DTE customer delivery.
  • Delivered/executed tests for System Integration/software update, Regression, Operational functions, and performance qualification for PKI Token Management, Transfer Management and Nonperson Entity projects.
  • Used Doors in designed/execution and traceability to SRS and SSS. Delivered design and operational qualification tests for certificate issuance, access control, token enrollment and key recovery, etc.
  • Designed/executed verification and regression for components of Public Key Infrastructure. Designed regression for token lifecycle covering all possible logical states, verifying results to DB using pgAdmin.
  • Using Linux shell monitored services for performance, and used Wireshark in verification of transactions.
  • Verified usability to customer expectation, with initial development on VMware system simulator. At various customer delivery events performed Operational Validation tests for PMO acceptance.
Confidential,Billerica, MA 

Senior Software Quality Engineer

  • Using QMS and 21CFR part 11 developed validation tests based on SOP for CAD simulation software. Investigated results from the CAD design to acceptance criteria for verification of and requirements.
  • Used Agile methodology while unit testing with dev and contributed to SOP procedure updates and usability.
  • Responsible for regression, used JIRA and SharePoint maintaining test traceability matrix to requirements.
Confidential,Cambridge, MA

Senior Software Quality Engineer

  • Engineered tests for computer generated object model for simulation war gaming C4I system.
  • Based on SS requirements designed/executed verification procedure on Test Manager.
  • Authored simulation game scenario for validation of use case. Created User Guide detailing event instructions and examples for expected behavior of simulated objects to requirement.
Confidential, Burlington, MA

Senior Software QA Engineer

  • Used QMS in design and execution of verification tests for Terumo cell expansion instrument.
  • Verified new workflow and business rule, timing of events and data recovery. Used Agile while unit-testing new functional features, used SharePoint for version control and Test Manager for requirement traceability.
  • Contributed to design review, iteratively conducted dry-run in evaluation of software release for defect fixes.
Confidential,Mansfield, MA

Senior Software QA Engineer

  • Designed/executed data integration/install, configuration, functional, and UI navigation tests in development support of molecular diagnostic PCR instrument.
  • Designed/executed verification for I/O data to/from XML and barcode and SOP update after deviation.
  • For assay development designed verification procedure for I/O data to/from XML and barcode.
  • Trained/participant in lab GMP and established ISO 13485 QMS for risk control and corrective action.
Confidential,Norwood, MA 

Senior Verification & Validation Engineer

  • Responsible for formal/informal verification & validation of Diabetic Care and Urine Chemistry instrument.
  • In support of QSR, 21CFR Part11 and premarket submission 510(k) verified SRS, SSS and business rules with tests designed test procedure for happy-path functionality, boundary, negative and exploratory analysis.
  • Designed/executed procedure for verification of patient sample, data recovery and security.
  • As subject matter expert, verified implementation of ASTM, HL7, POCT1-A against LIMS/HIS simulator.
  • Used DOORS for requirement and test case traceability, ClearQuest for defect management.
Confidential,Boston, MA

Senior Test Integration Engineer

  • Used Mobile devices, Linux, MSAD, VMware in development of test environment for validation of software.
  • Developed verification procedure for Web and mobile Apps, developed tests for enterprise micro blogging and social media. Responsible for release of beta software to 4000+ internal customers on three continents.

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