As a Senior Software V&V Engineer at Medtronic, you'll be responsible for the verification and validation of software for complex electro-mechanical medical devices, particularly within surgical robotics. This hands-on role involves developing cutting-edge testing strategies, implementing automation, and ensuring rigorous compliance with industry and government regulations. You'll contribute to a highly professional, geographically distributed software team, helping to champion healthcare access and innovation.
A Day in the Life
You will drive software quality and regulatory compliance by:
- Executing and documenting software tests using both manual and automation methodologies.
- Developing thoughtful testing strategies and protocols aligned with state-of-the-art software best practices.
- Developing test strategies, reviewing test designs, and validating test scripts for Surgical Robotic Medical Systems.
- Providing support for Non-Product Tool Validation (NPTV).
- Navigating complex industry and government regulations, including IEC62304, IEC82304, and FDA Quality System Regulation (QSR) requirements.
- Developing, documenting, and testing software to meet end-user needs and business goals.
- Assisting development teams and maintaining a commitment to project goals and timelines.
- Collaborating effectively with other disciplines to develop system-minded implementations that consider safety, performance, communication, and user interface.
- Working in a cross-functional Agile team across global R&D to test software for new and existing medical device products.
- Participating in reviews of requirements, design, implementation, and testing to ensure quality standards are met.
- Analyzing unexpected, undesirable, or non-understood behavior in software and in interactions of software with hardware.
- Documenting results of defect analysis.
- Following the IEC 62304 standard and project documents like software development plans and coding standards.
- Participating in other quality assurance functions, including static code analysis, risk/hazard analysis, and test automation development.
- Meeting key business KPIs/project metrics.
Required Knowledge and Experience
- Bachelor's degree in Computer Science, Electrical, Electronics, or equivalent from a reputed institution.
- 4 to 8 years of experience in Embedded Software verification & validation.
- At least 2 years of experience in the Medical Device/Medical IT or a regulated industry.
- Experience in test automation, preferably using Python.
- Knowledge in C++ software OS/RTOS in an Embedded development environment.
- Experience in both white box and black box testing and strong debugging skills.
- Experience in hardware/software interfacing and design issues.
- Participation in system design, coordination with teams, and internal product management.
- Experience/Knowledge of Networking protocols and 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 process like Agile/Lean.
- Must be a great individual contributor and team player.
- Possess qualities including being positive, having high standards, being resilient, open, and creative.
- Appreciation of the discipline and work required to develop software in a regulated industry.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package. We are committed to our employees, recognizing their contributions and providing resources to support you at every career and life stage.
About Medtronic
Medtronic leads global healthcare technology, boldly attacking the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people, leveraging talent, diverse perspectives, and courage to engineer the extraordinary.
