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Senior System Software Design Assurance Engineer Resume

Redmond, WA

SUMMARY

  • Expertise developing high quality tests and root cause identification of issues and implementation of logical, reliable fixes in an FDA regulated environment (IEC 62304, 21 CFR 820.30, ISO 13485, ISO 14971). Experienced leading firmware verification efforts with commitment to business expectations and technical growth of team members.

TECHNICAL SKILLS

Programming: Python, C++

Other Software: DOORS, JIRA, Rational ClearCase, ClearQuest, SQL, MS Visual Studio, HP Quality Center, MKS Integrity, AccuRev

Operating Systems: Microsoft Windows

Hardware: Oscilloscopes, multimeters, function generators, DC power supplies

PROFESSIONAL EXPERIENCE

Confidential, Redmond, WA

Senior System Software Design Assurance Engineer

Responsibilities:

  • Designed and implemented automated system software tests for multiple features including the critical AED (Automatic External Defibrillator) feature.
  • Found multiple issues with the AED feature workflow which resulted in a re - write of 20% of the Systems requirements for the feature

Confidential, San Diego, CA

Software Test Engineer

Responsibilities:

  • Designed and implemented tests for software applications for Medical Diagnostics Instruments based on Software Requirements Specification (SRS) and Product Requirements Document (PRD) for multiple diagnostic assays.

Confidential, Sunnyvale, CA

Senior Firmware Verification Engineer

Responsibilities:

  • Led firmware verification effort for critical fix to portfolio of implantable cardioverter defibrillators (ICDs) to ensure delivery of high-voltage therapy due to electrical short in system. Completed project with high quality and decreased delivery time by 25% to meet business needs
  • Led a 1 1/2 year, cross site (US and Sweden), 40+ engineer firmware verification effort for the Ellipse and Assura family of devices that showcase multiple new features including expanded protection against inappropriate shocks
  • Designed, implemented, and managed timing sensitive automated test suites in C++ for multiple complex algorithms and supported product development, by assisting firmware requirements, development, and systems in quality control
  • Provided technical leadership and mentoring to various feature teams in verification processes including requirement analysis, test strategy/planning, test design, test code development and review process
  • Represented verification team during multiple internal audits
  • Partnered with Quality Assurance (QA) and process teams to update firmware verification processes and guidelines to improve productivity and decrease issues during audits
  • Worked with Product Surveillance to process medical device complaints on defibrillators and leads as part of the remediation effort

Confidential

Software/Firmware Verification Engineer

Responsibilities:

  • Designed, implemented, and managed timing sensitive automated test suites for multiple complex algorithms and features
  • Gained domain knowledge and provided input on analyzing root cause issues from regression runs and improving tests to other team members for their features
  • Ported assigned features to new test setup while also improving stability of the tests by 25%
  • Improved Visual Basic tool and updated SQL queries to extract and add regression run results to tests database
  • Partnered with engineer and ported entire suite of tests from Borland C++ to Visual C++

Confidential

Software Verification Engineer

Responsibilities:

  • Developed, executed and reviewed manual and automated test procedures with supporting scripts and libraries for verifying software requirements for the Programmer/Recorder/Monitor (PRM) platforms
  • Trained test developers on testing methods for programmer software features
  • Provided support to external contract house working on programmer software testing

Confidential

Software Engineer

Responsibilities:

  • Lead project for software enhancements to Pacemaker Programmer application. Responsible for 4 people, 6 months project
  • Developed Web Based Application for Automated Review of Programmer screens using ASP, JavaScript and VBScript. Simplified screen review process and reduced review time by 66%
  • Coordinated with multiple Programmer software development groups and Guidant Europe country managers for additions/changes of foreign text, for 7 languages
  • Worked with multiple, cross-functional groups to provide support for Pacemaker and ICD field issues. Determined root causes, recommended, implemented solutions, performed testing and documented findings
  • Created tests for verification of Pacemaker and ICD firmware implementation against documented requirements as well as analysis of requirements for correctness and consistency

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