Quality Assurance Qa Engineer

DAVID LUIZ

North Andover, Massachusetts

978-***-**** ********@*****.***

http://www.linkedin.com/in/davidluiz777

Summary

Skilled Senior QA Engineer in both the Medical Device (Class 2 and Class 3) and Consumer software industry with many years of progressive software QA experience. Experienced in manual testing of Robotic Assisted Surgery Systems, I2C based embedded systems and insulin management systems. Strong hardware and technical background in both analog and digital technologies. Results driven problem solver, able to quickly grasp complex systems and identify opportunities for improvement and resolution of critical issues. Proven ability to lead, influence and support cross functional teams in alignment with projects and organizational goals.

Technical Summary

Languages: C, C++, and Python

OS: Windows, MacOS, Linux, iOS, and Android

Frameworks: TCP/IP, HTTP

Processors: MySQL, ASP.NET

Tools: Helix ALM, Jama ALM, Matrix Requirements, DOORS, Agile PLM, Git, GitHub, Jira, Confluence, Keil, Subversion, Code Warrior, VMWare, TFS, MS Project, MS Office, TeraTerm, TeamTrack, SourceTree, SourceSafe, Bugzilla, FogBugz, Inno Setup, InstallShield, and MSI Installer

Other: Trained in ISO 13485, IEC 62304, ISO 14971, and FDA 21 CFR Part 820 Standards

Key Relevant Experience

Nova Biomedical – Waltham, MA March 2023 - March 2025

Senior Quality Assurance Engineer

Performed dry runs and verification/validation testing for two specific blood analyzers.

Generated test metrics in order to improve testing efficiency and quality.

Updated test requirements, protocols and test scripts, as well as trace matrices.

MedAcuity Software, LLC – Westford, MA February 2018 - January 2023

Senior Quality Assurance Engineer/QA Test Lead – Robotic Assisted Surgery System Jul 2020-Jan 2023

QA Test Lead for 8 co-workers in 4 teams for 2 shifts in 2 labs utilizing 2 Robotic Assisted Surgery Systems and responsible for delegating and balancing tasks for each team and labs. Generated weekly status reports for the project manager and coordinated workflow with the client Product Manager.

Performed hands on manual and automated testing, running propriety Python scripts while manipulating multiple robotic arms with instruments, endoscope, and various subsystems with the surgeon console.

Exercised all aspects of the multiple displays, LED states and patterns, including 3D imagery.

Ability to troubleshoot robotic arm, surgeon console, main controller to the subsystem level and provide logs to the development team.

Executed developed protocols containing several test cases during formal verification and validation and created test execution reports including objective evidence and log files.

Provided feedback and optimized test cases which improved efficiency and productivity.

Performed regression testing and provided feedback directly to the developers.

Trained new team members on all aspects of the robotic assisted surgery system and subsystems as well as expected processes.

Software Quality Assurance Specialist – Insulin Management System Jun 2019- Jul 2020

Defined and executed requirements-based test procedures for an insulin management system on an I2C embedded system development board utilizing Bluetooth Low Energy (BLE) communication via proprietary Android device

Researched, implemented and trained two SQA test teams with the Saleae Logic Analyzer which improved capturing of objective evidence during V&V testing and increased efficiency and productivity by at least 30%. All appropriate test cases were updated to utilize this new device.

Testing complex applications and I2C based embedded systems utilizing manual white box and black box protocols with proprietary tools as well as logic analyzer, oscilloscope, DMM and Sodera Bluetooth sniffer

Updated several hundred test tool scripts to display improved user feedback.

Executed tests in formal V&V test execution cycle and created test execution reports

Recorded defects in tracking system and worked with development team to isolate and resolve issues

Working knowledge of Helix ALM, Jira, Confluence and Matrix Requirements software

Software Quality Assurance Specialist – Insulin Management System Feb 2018-Jun 2019

Authenticated insulin management system (Class II) utilizing web-based environments and iPhone and Android integration

System leveraged web and mobile components to allow patients to view/manage dose plans and compliance

Created and executed test cases with traceability for verification protocols

Recorded defects in tracking system and worked with development team to isolate and resolve issues

Worked effectively with multidisciplinary stakeholders at various levels within a client organization

Worked in Agile environment

Familiar with cloud-based environments and browser specific developer tools

Akamai Technologies, Inc. – Cambridge, MA February 2017 – January 2018

Platform Operations Technician - NOCC

Resolved technical issues using proprietary alert management system software

Escalated issues, both internally and externally, to resolve provider connectivity issues, while working closely with Operations teams

Work with peers to improve tools, alerts, documentation, and procedures

Cakewalk, Inc – Boston, MA March 1997 – June 2016

Principal Software Quality- Build and Release Engineer

Designed and developed setup programs using Inno Setup, configured entities and applications in Inno Setup and collaborated with the Product Management team

Maintained ‘Builds’ code repository using Kiln (Mercurial) version control

Provided Setup related assistance by pretesting on different environments, debugged and fixed issues faced in installation of setup

Organized files related to each application build and allowed much more efficient updating of new content and data

Maintained build versions and deployment of beta and release applications

Senior Software Quality Engineer

QA Lead and managed beta programs for over a dozen consumer level audio applications and plugins

Participated in daily meetings, which included team members from Product Management, Development, Documentation, QA, and Customer Care

Involved in design review meetings from product inception, new features, and general functionality

Defined test plans, procedures, test cases, test scripts and reviewed test cases generated by other team members to ensure clarity, accuracy, and efficacy

Defined and implemented procedures for functional, load, performance, and stress tests which allowed a more focused review of the application and its performance

Experienced in localization testing

Developed roadmap for beta testers from process steps to Beta Administration Handbook widely adopted by all beta administration teams. This led to the beta testing team to become more productive in days rather than weeks

Led organizational effort to bring QA standards to the highest level by enlisting new team members, work with individual testers and escalate issues when appropriate

Monitored and verified the quality of each beta tester bug report and assigned to the appropriate developer

Responsible for organizing and maintaining all beta reports, then presenting a summary of results in daily or weekly development status meetings

Defined test procedures and processes for audio hardware compatibility and performance within all applications which allowed manufacturers to address issues prior to release

QA Engineer

Worked diligently to create test scripts and test plans to test compatibility of audio and MIDI devices within the application

Researched and implemented a system imaging process, using tools such as Norton Ghost and VMWare Workstation tools, to streamline operating system and localization testing

Assisted in developing new processes, procedures and testing enhancements for new products

Worked with 3rd party hardware manufacturer to integrate components that saved $10,000 over the course of the project

Additional Skills and Experience

Worked in the defense electronics industry for 10+ years, managing several manufacturing teams, and held a secret clearance during that time

Experienced in Autodesk Eagle Schematic Capture and PCB Design

Education

UNIVERSITY OF LOWELL, Lowell, MA

Music Theory and Composition

BERKLEE COLLEGE OF MUSIC, Boston, MA

Music Theory and Composition

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