Medtronic Cardiac and Vascular
Location
Secunderabad | India
Job description
Careers that Change Lives
The senior Software test engineer will be responsible for software design a nd 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 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 regulated industry.
. Knowledge in C++ software & 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.
. Excellent debugging skills and problem-solving capabilities
. Experience working in a structured software development enviro nment 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
Nice to Have
. 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
. At least two (2) years' experience in the Medical device/Medical IT
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