Bio
Experience
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ScottCare Cardiovascular Solutions
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Cleveland/Akron, Ohio Area
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Software Quality Assurance Team Lead
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May 2019 - Present
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Cleveland/Akron, Ohio Area
ScottCare provides medical systems and software solutions for cardiovascular diagnostic monitoring and cardiac rhythm device management.• Formulate verification and validation test plans, protocols and reports to ensure design verification & validation deliverables comply with design controls & medical device standards like IEC62304.• Analyze test results for completeness and correctness and assure coverage of requirements.
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Test and Verification Solutions
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Cleveland, Oh
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Member of the Technical Staff
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Jan 2019 - Apr 2019
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Cleveland, Oh
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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Senior System Verification Test Engineer
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Jan 2005 - Dec 2018
• Extensive experience in developing verification test plans, protocols, trace matrix and reports• Submission of detailed defect records resulting in defect investigations to identify the root causes of test execution failures• Led and coordinated activities of both small and large test teams• Experience in requirements analysis and development• Extensive track record of meeting global program deliverables compliantly, on time and consistently, • Worked as a key member of a global cross-functional project team member• Participated in defect management throughout the software development life-cycle• Major contributor to Verification process simplification workshopSystem Verification/Software Quality Test Engineer JAN 2001 to Dec 2018•Responsible for execution of system, integration and regression testing of both software and hardware components of medical devices.•Generation of verification test protocols to cover system software and hardware requirements
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System Verification Test Engineer
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Jan 2001 - 2005
•Responsible for execution of system, integration and regression testing of both software and hardware components of medical devices.•Generation of verification test protocols to cover system software and hardware requirements resulting in comprehensive test scripts that assured compliant test coverage of requirements.
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Software Validation Technician, R&D, SQA Dept
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1997 - 2000
Division of Bayer Corporation, International manufacturer of diagnostic medical equipment, formerly, Chiron Diagnostics and Ciba Corning Diagnostics. • Wrote test scripts based on system requirements and in charge of all script edits. • Ensured hard-copy scripts for each pass of testing was in order and archived according to process. • Worked directly with Software Engineers to ensure system requirements were implemented and Work Instructions were updated accordingly. • Experience testing system requirements on diagnostic medical equipment to produce high quality/reliable systems• Participated on Process Action team to create work instructions for writing of tests scripts for SW department.• Clinical background used to optimize medical device testing
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Education
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West Virginia Northern Community College
Associate of Science - AS, Clinical/Medical Laboratory Technician -
Youngstown State University
Bachelor of Applied Science - BASc
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Industry Focus. “Medical Devices”
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