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.
- Test Automation
- SW & HW VandV
- Team Leadership
- SW Quality
Senior Software Quality Engineer
- 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.
Principal Software Verification Lead
- 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
- 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.
Senior Test Engineer
- 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.
Hardware Design/System Validation Engineer
- 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.
Senior System Validation Engineer
- 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.
- 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.