Embedded Software Test Engineer
1 month ago
Careers that Change Lives
The senior software test engineer will be responsible for software design and development activities of complex electro-mechanical medical devices. This engineer will be a part of a small but highly professional and geographically distributed software team.
A Day in the Life
• Execute software testing and document results using manual and/or automation methodologies.
• Develop thoughtful 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 NPTV (Non-product tool validation) support.
• Navigate industry and government regulations, including IEC62304, IEC82304, and FDA QSR (Quality System Regulation) requirements.
• Develop, document, and test software to ensure it meets end-user needs and achieves business goals.
• Provide assistance to development teams.
• Commit to achieving and exceeding project goals and timelines.
• Thrive 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 software behavior and interactions with hardware.
• Document results of defect analysis.
• Follow the IEC 62304 standard and project documents such as the software development plan and coding standards.
• Participate in other quality assurance functions, including but not limited to static code analysis, risk/hazard analysis, and test automation development.
• Be an excellent team player with good communication skills.
• Meet key business KPI/project metrics.
Must Have
Minimum Qualification
• Bachelor's degree in Computer Science, Electrical, Electronics, or equivalent from a reputable institution.
• 4 to 8 years' experience in Embedded Software verification and validation with at least 2 years' experience in the Medical device/Medical IT or regulated industry.
• Test automation experience preferably using Python.
• Knowledge in C++ software and OS/RTOS in an Embedded development environment.
• Experience on both white box and black box testing and strong debugging skills.
• Experience in hardware/software interfacing and design issues.
• 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.).
• Experience 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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