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Work Background
Moog Inc.Software Quality Engineer
Apr. 2022 - Sep. 2023Salt Lake City, Utah, United StatesLead the development, implementation, and maintenance of software quality processes to ensure compliance with FDA (FDA 21 CFR 820.30), ISO 13485, and other relevant standards(IEC 82304/62304, SaMD/SiMD). Collaborated with cross-functional teams to facilitate the design and development of compliant medical device software. Conducted risk analysis and implemented risk mitigation strategies to enhance product reliability and safety. Provided guidance in developing test strategies, test cases, and test scripts for various projects, resulting in solid regulatory compliance and mitigation of potential risks to the customer. Reviewed, edited, and approved software documentation, ensuring robust documentation practices that meet regulatory standards. Acted as a pivotal communication point between software developers, system engineers, and product managers, ensuring smooth collaboration and understanding of quality requirements. Explored Generative AI as a tool to aid in Risk Analysis for Medical Devices and Medical Device Systems.
Gene Arguelles LLCIT Consultant and Business Owner
Oct. 2019Aldie, VACurrent white paper project proposals in Applied AI (Prompt Engineering), Data Analytics and Quantum Computing.
Self-employedOwner - Gene Arguelles LLC
Jun. 2016 - Oct. 2019Washington DC and Northern Virginia
Gene Arguelles LLCSoftware Test Analyst (Subcontractor)
Mar. 2013 - Sep. 2019Falls Church VASystems Integration Tester for the Joint Theater Medical Information Program (TMIP-J) framework. Test scope including all associated applications of TMIP-J: Theater Advanced Healthcare Longitudinal Technology Application (AHLTA-T), Neuro-Cognitive Assessment Tool (NCAT), Maritime Medical Module (MMM), Theater Management Information Program (TMIP) Reporting. Validated data migration processes. Oracle database testing: queries (SQLplus), patch installation and upgrade validations using Oracle database utilities. Other database experience: PostgreSQL testing. Documentation: wrote test plans, procedures and final reports as part of overall testing duties. Investigating/researching current active reporting tool for viability as repurposed tool for data analytics (currently as proof-of-concept only).
SAICSoftware Test Analyst (subcontractor)
May. 2011 - Sep. 2012Falls Church, VASystems Integration Tester and QA Analyst for the Joint Theater Medical Information Program (TMIP-J) framework, Theater Advanced Healthcare Longitudinal Technology Application (AHLTA-T). Tested all associated applications of TMIP-J: Neuro-Cognitive Assessment Tool (NCAT), Maritime Medical Module (MMM), TMIP Reporting. Validated data migration processes. Oracle database testing: queries, patch installation and upgrade validations. Documentation: wrote test plans, procedures and final reports as part of overall testing duties. Provided training and mentorship for new hires.
Headquarters Air ForceConsultant/QA Analyst
May. 2009 - Mar. 2011Rosslyn, VATest Automation programmer and test lead for the Air Force Warehouse Management System (WMS). Test automation development for Air Force Complaint Tracking System (ACTS), Performed test automation training and consultation for Air Force software testers. Designed and implemented test automation framework for headquarters Air Force. Test automation frameworks implemented within certified RUP or Agile environments. Tested applications built under .net and Cold Fusion development environments.
i3 CorporationConsultant/QA Analyst
Mar. 2009 - Mar. 2009Installed/upgraded Rational Robot. Wrote automation scripts to assist client with their next testing project.
Metron CorporationConsultant/QA Analyst
Dec. 2008 - Jan. 2009Test planning and execution of the Federal Aviation Administration Departure Flow Management system (FAA DFM system). Primary duties: manual test execution covering all of the functional specs, defect reporting and defect fix validation. Back end database testing utilizing SQL on DB Visualizer and Oracle 10g Enterprise Management to test Java MBeans. Defect Tracking utilizing JIRA.
Joel Bradshaw, Inc.Consultant/QA Analyst
Jun. 2008 - Sep. 2008Test planning and execution of the US Army Planning Programming and Budgeting Business Operating System (US Army PPB BOS). Test planning activities included requirements gathering and analysis, documentation and test environment design and setup. Tested web-based application, SOAP components, Oracle database. Drafted test plans for modules: Delivered Media Archive (DMA), Briefing Generations, Centralized User Role Management (CURM). Drafted test plans for data warehousing operations and test automation. Initiated Risk Analysis into the test plan process.
Cryptek, IncConsultant/QA Analyst
Oct. 2007 - Jan. 2008Built automated test framework for encryption and document management software products: Joint Technical Data Integration (JTDI) Data Input Module (DIM) Drawing Adapter. Also worked with testing Joint Engineering Data Management Information Control System (JEDMICS). Test automation framework built with Rational Robot. Test environment built by installing and setting up the following components: Sun/UNIX OS, MySQL database and test application servers (OAI and DIM server). Hardware: Dell PowerEdge 2950 servers and Dell Latitude D520 laptops for client nodes. Network testing tools: Wireshark network management and analysis.
Joel Bradshaw Inc.Consultant/Network QA Engineer
May. 2007 - Jul. 2007for VeriSign: Initiated test plan creation for Verisign datacenter consolidation project. Test plan coverage focused on network testing and spanned component test phase through system level validation. Network testing tools: Solarwinds network management and analysis tools, Wireshark network analysis tools.
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