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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