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Senior Software Quality Engineer Resume

SUMMARY:

Computer Engineer with strong Confidential regulated medical device experience involving automated/manual software, hardware, system level product testing. Strengths include coordinating domestic and off - shore engineering teams. Exceptional teamwork, problem solving and communications skills.

EXPERTISE AREA:

  • Test Automation
  • SW & HW VandV
  • Team Leadership
  • SCRUM/Agile
  • SW Quality

EXPERIENCE:

Confidential

Senior Software Quality Engineer

Responsibilities:

  • Coordinate and implement software verification of Confidential regulated products and non-product software validation (IQ/OQ/PQ).
  • Work closely with R&D and manufacturing teams to produce documentation including plans, protocols, risk assessments (FMEA/FMECA) and traceability.
  • Perform software quality oversight of manufacturing systems to maintain validated state for Confidential and other regulatory audits.
  • Reviewing process and procedures as part of a total quality improvement effort.

Confidential

Principal Software Verification Lead

Responsibilities:

  • Planned and coordinated all software design verification activities for three full product releases of the Confidential flagship ( Confidential Class III regulated) software suite MedNet (HMSS, DLE) including regulatory audits with no observations.
  • Decreased product time-to-market by at least 80% by increasing test automation to over 75%, and achieved comprehensive requirements testing of 100% coverage while undergoing a 40% reduction of staff and 75% off-shoring of staff.
  • Directly responsible for verification staff of up to 8 engineer direct reports and teams of between 25 and 45 automation and manual test developers.
  • Facilitated the development of over 12,000 automated scripts and manual protocols testing both Java browser-based software and compiled binary client/server software.
  • Conducted requirements reviews, defect triages, code reviews and non-product tool validations. Wrote test plans/reports, traceability matrices, procedures and processes. Tracked team performance, velocity metrics and ISO status.

Senior Software Verification Engineer

Confidential

Responsibilities:

  • Developed Ruby/TCL Automation scripts to verify embedded software requirements for Confidential Class III regulated Infusion devices and Intravenous Clinical Integration (IVCI) platform.
  • Assisted in designing, troubleshooting, and maintenance of test framework, APIs and other software test automation tools.
  • Produced tool validations for test framework, APIs and other test utilities. Provided and support to fellow team members.

Confidential

Senior Test Engineer

Responsibilities:

  • Tested hardware and software telemetry systems for integration and release.
  • Participated in factory acceptance tests (FAT), site acceptance tests (SAT), system integration, applications engineering and marketing support activities
  • Created, executed and delivered test plans, test procedures, test results, coverage and performance plans.

Confidential

Hardware Design/System Validation Engineer

Responsibilities:

  • Validated point-of-service (POS) system hardware components for integration and approved addition to product bill of materials.
  • Developed, debugged and validated embedded firmware solutions for USB based sub-assemblies in POS systems. These included sensors and interface control systems using PIC and 8051 microprocessors. Performed all USB related troubleshooting, testing and compliance testing.
  • Evaluated components for RoHS and WEEE compliance using XRF analyzer.

Confidential

Senior System Validation Engineer

Responsibilities:

  • Designed, and implemented hardware solutions to enable thorough testing of advanced Server Manageability products implemented as ARM processors embedded in blade servers, with particular focus on SMBus, I2C, IPMB, and inter-device serial communications.
  • Conducted server hardware technology and laboratory equipment instruction to firmware development and validation staff.

Confidential

Verification Engineer

Responsibilities:

  • Designed embedded test framework and firmware in order to conduct pre/post-silicon design verification of ASIC RS232 to SPI/I2C and USB embedded host products.
  • Utilized 16-bit RISC microprocessor, IAR Embedded Workbench, pattern generator, logic analyzer, oscilloscope and other tools to exercise Confidential emulation and production devices under test.

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