Senior Software Test Engineer - (V &V and C++ ) - Embedded C++ , Test Automation ,Python
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.
· 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.
Must Have
Minimum Qualification
· A Bachelor’s degree in Computer science, Electrical, Electronics / equivalent from reputed institution.
· 4 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/Knowledge of Cyber Security testing (encriptions, authentications etc.)
· 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, Embedded SSL/TLS Libraries and Know-how of field-bus technology (EtherCAT preferred) and standard embedded communication protocols (DDS, SPI, I2C, AXI, UART, etc.)
· 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
