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Mariana Gavrila

3rd

Previous positions

  • Software Test Engineer/Systems analyst at Hologic, Inc.
  • Quality Assurance Inspector at Qualcomm

Education

Vasile Alecsandri Engineering University of Bacău, Romania, Bachelor’s degree, Engineering

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Background

Summary

Motto: I gain strength, knowledge, and confidence from every experience I encounter. With each new day comes new opportunities. Executive Summary: • Experience in Software Verification and Validation, Trace Matrix and Testing reports for medical devices including Medical Software for Diagnostics Instrumentation in both Clinical Diagnostics and Blood Bank Markets • Strong knowledge of SDLC procedures including AGILE/SCRUM methodologies • Strong knowledge of Regulatory / Compliance requirements for medical software • Expertise in Requirements Definition / Analysis / Use case development • Tested environment with LIS integration system • Molecular diagnostic testing thru TMA (transcription-mediated amplification) and PCR (polymerase chain reaction) technique for multiple valuable chemistries on a single platform • Practical experience with SQL Server Database • Strong analytical and troubleshooting skills including the diagnoses of system issues (hardware and software) and performing root cause analysis • Using quality and requirement management systems effectively and efficiently to further project goals and meet deadlines; Experience with Telelogic Doors, DevTrack, TestTrack, HP Quality Center, TFS, JIRA, FogBugz, SpiraTeam • Helped develop QMS system for achieving organization’s quality objectives and customer requirements, improving the effectiveness and efficiency • Familiar with a variety of software systems and hardware/test system • Knowledgeable and effective in agile development environments as well as other development methodologies including, scrum, waterfall, incremental and spiral • Strong customer service skills, analytical, problem-solving, and conceptual skill • Team player, flexible, creative, motivated and hard-worker

Experience

  • Senior Software V&V Engineer (Consultant)

    SMEDIX Inc

    March 2016 – Present(3 years 7 months)San Diego, CA

    Responsibilities: Working within a team and being responsible for input and review of software requirements along with software design decisions; Review of software requirements for accuracy and testability; Creation of test strategies for requirements; Creation of test procedures (based on requirements, software design documents and test strategies); Bug identification and reporting; Software verification and validation documentation; Tested device that helps improving health and well-being of people by optimizing sleep quality and developing solutions for disorders related to the narrowing of the airway during sleep, such as obstructive sleep apnea (OSA); Worked on the development of newest instrument platforms, including testing updates to existing tools, or creation of new software tools used internally at the client site; Worked with automated slide staining systems, used for tissue based cancer detection and diagnostic; Defined and Implemented Software Lifecycle Process (all phases) using Agile software methodology while maintaining compliance with FDA and other regulatory bodies; Identified and installed process tools (Doc management, Configuration Management, Defect tracking, etc.); Completed Traceability Report and Testing reports using defined processes.

    Recommendations (3)
  • Software Test Engineer/Systems analyst

    Hologic, Inc.

    December 2013 – March 2016(2 years 3 months)San Diego Area

    Responsibilities: Worked on projects related to testing of software for highly complex medical devices/instrumentation; Troubleshooted instrument problems, improvements or complaints; Reviewed data and recommend courses of action; recommended project priorities; Performed laboratory work to assure completion in accordance with established safety procedures and applicable regulatory regulations; Interfaced with programming staff, marketing and QA; Reviewed SOPs for regulatory compliance; Assisted with creation of Tools validation protocols; Executed complex test protocols; Planned and performed unit, integration, system, user acceptance, regression and performance testing through automated tests and Black Box testing; Set up test environments for developers and me, also estimated time and difficulty for test activities; Documented software issues clearly and concisely in MKS tracking system through complaints; Provided training to different team members on procedures, verification and validation of the system; Participated in Scrum meetings and sprint planning; Created test plan development and root cause analysis; Produced high-quality, timely work that supported team objectives; Communicated effectively with colleagues from various teams (Development, V&V, Service) to find/give solution to different SW issues; Sent feedback and followup e-mails to development team, to get the build stabilized faster; Designed test cases around requirements and specifications; Helped requirements team create/update documentation for the Fusion system; Interviewed possible candidates for our development lab; Maintained lab organization, so it’s easy for everyone to work more efficiently; Helped organize different team events (team building).

    Recommendations (5)
  • Quality Assurance Inspector

    Qualcomm

    May 2012 – October 2013(1 year 5 months)

    Responsibilities: Performed chipset evaluation based upon engineering requirements and specifications, utilizing bench test equipment like Verigy 93K/ Teradyne, EDGE/EPSON/SYNAX handlers; Familiar with Oscilloscopes, Spectrum Analyzers, X-ray and ICOS machine, SLT surf boards; Worked with multiple projects and different programs like Oracle, Agile-Salesforce, LabView; Used Linux in SOC Lab with ATE equipment; Experienced with laser etching devices; Performed audits; Reported test results and status using strategies and standards defined by the QA department; Maintained QA processes and standards in new projects and assisted in the definition of new processes; Ability to document, track, and verify the resolution of defects; Familiar with Semiconductor Operations and Manufacturing – thorough knowledge and strong background in dealing with Foundry, Assembly, Test, and Supply Chain flows.

    Recommendations (2)

Education

  • Vasile Alecsandri Engineering University of Bacău, Romania

    Bachelor’s degree, Engineering

    2005 – 2009

  • N.V. Karpen High School, Bacău, Romania

    High School Degree, Computer Operator

    2001 – 2005

Languages

  • English

    Native or bilingual proficiency

  • Romanian

    Native or bilingual proficiency

  • Spanish

    Limited working proficiency

Skills & Expertise

  • Software Verification
  • Engineering
  • Snow Leopard
  • Test Cases
  • Sales
  • Unit Testing
  • Customer Oriented
  • Labview
  • Interviewing Skills
  • Manufacturing
  • SOP development
  • Root Cause Analysis
  • Teradyne Flex
  • Temptronic Thermostream
  • Microsoft Office
  • Program Management
  • Test Planning
  • Outstanding time management skills
  • Management
  • JTAG
  • Medical Device R&D
  • FDA
  • Software Development Life Cycle
  • User Acceptance Testing
  • Test Validation
  • Medical Devices
  • Delta Edge, Seiko Epson and Synax Handlers
  • Software Quality Assurance
  • Functional Testing
  • Software Requirements
  • Debugging
  • Test Engineering
  • Integration Testing
  • Product Development
  • Analog Circuits
  • Agile Testing
  • Salesforce.com
  • Regression Testing
  • Quality Assurance
  • Verigy 93K
  • Oracle Agile
  • Laser Marking
  • Black Box Testing
  • Software Development
  • Performance Testing

Volunteer Experience & Causes

Causes Mariana cares about:

  • Education
  • Health
  • Science and Technology