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, MASenior 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.
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.
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.
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.
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.
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.
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.