JAMES SHELEY

San Jose, CA 95124 408-533-5607 jksheley@sbcglobal.net

SOFTWARE QUALITY ASSURANCE ENGINEER

Dedicated engineering professional with extensive software quality engineering experience in medical device industry. Consistent contributor to successful planning and completion of small to large, complex projects within tight deadlines. Frequent mentor to new team members to bring them up to speed quickly on critical test procedures and system features. Core Technical Skills and Expertise Software QA testing process; test strategies, test plans, test protocols, and test reports; system-level Black Box testing Test and debug: C#, C++, and XML applications on Windows and Unix applications Writing and execution of test procedures for verification and validation system requirements Experienced with planning, writing, and executing test procedures for large, complex and embedded control systems FDA Regulated Environment-Class II, Class III Knowledge of design control and software quality processes Knowledge of related standards for software design and development for embedded medical device systems Experienced in use of test tools, including JIRA, Rational Clear Quest, DOORS, Test Manager, Quality Manager, Clear Case, Agile, Perforce and Jenkins/Hudson

PROFESSIONAL EXPERIENCE
Home Dialysis Plus, Sunnyvale, CA Nov 2013-April 2014 Software Quality Engineer TM Developed and executed validation and verification (V&V) test protocols and reports for Tablo hemodialysis system. Provided oversight and guidance to software team in its approach to development processes and established department procedures in alignment with 13485. Provided leadership to test teams, including establishing test strategies, monitoring deliverables, and coordinating resources to ensure on-time completion. Managed, trained and coordinated new contract software testers to overcome compressed schedule for developing and executing Software System and Alarm Protocols for 510k submission. Key Actions: Collaborated with software and R&D groups to develop, dry run and execute test protocols. Managed personnel and test equipment scheduling. Ensured configuration alignment met requirements and functionality. Volcano Corporation, Rancho Cordova, CA Feb 2013Oct 2013 System Test Engineer Developed and executed validation and verification test plans and reports for the Volcano CORE Control Pad a secondary controller in Volcano CORE Precision Guided Therapy Systems. Selected Achievements: Led V&V activities to complete testing deliverables for Volcano CORE Control Pad. Key Actions: Collaborated with engineering and project management on creating and reviewing verification and validation test plans, procedures and reports for submission into agile. Mentored team members on new system features. Accuray, Inc., Sunnyvale, CA 20072013 Software Quality Assurance Engineer Develop and execute validation and verification (V&V) test plans and reports for CyberKnife Robotic Radiosurgery System. Contribute expertise to completion of major projects and provide leadership on smaller projects, including establishing test strategies, monitoring deliverables, and coordinating resources to ensure on-time completion. Assist database group with cross-over projects, including environment and testing aspects. Mentor team members on new and existing system features.

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Selected Achievements: Reduced setup and scheduling time for automatic build from 4 hours to 20 minutes. Key actions: Mastered unfamiliar technology to enable automation of build-and-release process. Selected easy-to-use configuration management tool and documented process to assist untrained or inexperienced individuals in its use. Led V&V activities to connect personal identification system to customers CyberKnife system. Key actions: Collaborated with engineering, database, and CDMS/DQA teams to obtain and communicate critical information. Developed patch build and media for treatment delivery testing. Created test cases, completed testing of assigned test cases, and logged anomalies in CQ. Tyco Healthcare, Pleasanton, CA 20062007 Software Quality Assurance Engineer (contractor) Created and executed software validation test protocols for simulated lung used in performance testing of new Respiratory Mechanics features. Participated in and contributed to test plan development, product requirement tracing, defect tracking and analysis, and reviews. Ensured proper configuration and calibration of test systems and equipment/tools. Selected Achievement: Overcame problem with calibration requirement for pressure sensors and executed Respiratory Mechanics control performance test procedures for 501k submission on schedule. Key actions: Coordinated with calibration manager and offsite engineering to retrieve calibration standard from National Institute of Standards and Technology (NIST) and expedite sensor calibration. Completed non-product validation of lung simulator on time Varian Medical Systems, Palo Alto, CA 20052006 Software Quality Engineer (contractor) Recruited to develop, execute, and maintain validation test plans for new service application used to set up and troubleshoot radiotherapy machines. Utilized hardware background to support electrical engineering and assisted manufacturing, hardware, and software engineering teams with multiple tasks. Applied Materials, Santa Clara, CA 19952005 Test Engineer, Associate Technical Trainer (contractor) Created and maintained simulator test environments for Quality Assurance activities. Requested to set up product simulators for all AMAT product lines; completed requirements within 30-day target period. Assisted engineering to reduce cost of ownership by creating software simulator templates. Developed programs for training, tool data analysis, and tool notification and monitoring applications. Application Quality Assurance Engineer Developed and implemented functional and automated test cases. Built and maintained QA test environment for releases of process application software that required data logging verification. Achieved 50% increase in uptime and improved mean time between simulator failures from 1 day to 30 days. Software Quality Assurance Engineer Generated, implemented and maintained functional test cases for Manufacturing Execution System software designed to monitor and control manufacturing processes that enhanced factory efficiency, time to yield and factory automation. Modified ISO procedures to include newly defined business processes, which improved quality and enhanced communication of performance expectations to customers. Initial position at Applied Materials: Test Engineer

EDUCATION AND PROFESSIONAL DEVELOPMENT

Bachelor of Science in Electrical Engineering (BSEE), San Jose State University, San Jose, CA Associate of Science in Electronic Technology (ASET), New Mexico State University, Alamogordo, NM Multiple courses at University of California, Santa Cruz, including Visual Basic Scripting, Building Data Structures, and C Programming