Job Description

Careers that Change Lives Thesenior Software test engineerwill be responsible for software design and development activities of complex electro-mechanical medical devices.The engineer will be a part of a small but a highly professional and geographically distributed Software team. A Day in the Life . Test execution and document software using manual and/or automation methodologies. . Thoughtfully develop testing strategies and protocols with state-of-the-art software best practices. . Develop test strategies, review test designs, and validate test scripts, verification of software for Surgical Robotic Medical System. . Provide support for NPTV (Non-product tool validation). . Navigate the complexities of industry and government regulations to include IEC62304, IEC82304 and FDA QSR (Quality System Regulation) requirements. . Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals. . Provide assistance to development teams. . Commitment to achieving and exceeding project goals and timelines. . Thrives in working with other disciplines to develop system-minded implementations that consider safety, performance, communication, user interface and other aspects of a final Medical Device product. . Work in a cross-functional Agile team across global R&D teams to test software for new and existing medical device products. . Participate in reviews of requirements, design, implement and test to ensure quality standards are met. . Analyze unexpected, undesirable, or non-understood behavior in software and in interactions of software with hardware. . Document results of defect analysis. . Follow the IEC 62304 standard and project documents such as the software development plan and coding standards. . Participates in other quality assurance functions, including, but not limited to, static code analysis, risk/hazard analysis, and test automation development. . Should be an excellent team player with good communication skills. . Should meet key business KPI/project metrices. Must Have: Minimum Requirements . A Bachelor\'s degree in Computer science, Electrical, Electronics / equivalent from reputed institution. . 8 to 12 years\' experience in Embedded Software verification & Validation with at least two (2) years\' experience in the Medical device/Medical IT or regulated industry. . Knowledge in C++ software & OS/RTOS in an Embedded development environment. . Experience on both white box and black box testing. . Experience in hardware/software interfacing and design issues. . Experience in test automation preferably using Python. . Participate in System design, coordination with teams and internal product management. . Experience/Knowledge of Networking protocols and Know-how of field-bus technology (EtherCAT preferred) and standard embedded communication protocols (DDS, SPI, I2C, AXI, UART, etc.) . Exper ience working on GTest / GMock . . Experience with software risk analysis (per ISO 14971) including software failure mode and effects analysis (FMEA). . Awareness of Medical Device standards IEC 60601-1, IEC 62304, ISO 13485, ISO 14971, and applicable FDA standards . Excellent debugging skills and problem-solving capabilities . Experience working in a structured software development environment following a well-defined software development process like Agile / Lean. . Must be a great individual contributor and team player. . Must have qualities including being positive, high standards, resilient, open, and creative. . Appreciation of discipline and work required to develop software in a regulated industry

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