Sr Software Engineer

A Day in the Life

Test execution and document software using manual and/orautomationmethodologies.

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.

Qualifications

Must Have

Minimum Qualification

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.

Experience developing test strategies for systems in a highly regulated industry.

Experience in developingtest automationsuites preferably usingPython.

Experience inC++software &RTOSin anEmbeddeddevelopment environment.

Experience on bothwhite boxandblack box testing.

Experience inhardware/software interfacingand design issues.

Excellent debugging skills.

Participate in System design, coordination with teams and internal product management.

Know-how of field-bus technology (EtherCATpreferred) and standard embeddedcommunication 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.