1163 Shewsbury Ave Shrewsbury NJ 07702
• In charge of Data Mining/Data Warehousing project to provide data for clinical trial FDA submissions (XMLMSSQL).
• Develop and execute Firmware & Software Black and white box test cases for implantable medical devices based on risk-based approach to unit testing.
• Follow FDA regulations and guidelines for code reviews, code coverage results, and project analyzer tool metrics to drive code testing priorities and concentration.
• Participate in all phases of the control and review of new product designs to assure:
Potential defects are eliminated at an early stage in the design process
Critical component and process capabilities are evaluated and included in the design process in
order to assure the end result is a "robust" design, including reviewing designs for sources of potential failure and for manufacturability.
• Participate in product and process risk assessment activities, including Hazards Analysis, and Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA) to ensure compliance to ISO 14971.
• Develop and execute test tools using VSTS2003VSTS2010 to verify medical device algorithms and functionalities.
• Assist development engineers in establishing reliability test techniques and test structure design for new and emerging technologies.
• Provide technical and development support for all Angel Medical Systems applications and tools.