Senior Enterprise Software Test Engineer

Responsibilities may include the following and other duties may be assigned

• 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.
• 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.

Required Knowledge and Experience

• A Bachelor s degree in Computer science, Electrical, Electronics / equivalent from reputed institution.
• 8 to 12 years experience in Software verification & Validation with at least two (2) years experience in the Medical device/Medical IT or regulated industry.
• Experience in test automation preferably using Java, Groovy, Selenium, Appium.
• Experience in 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 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

Medtronic offers a competitive Salary and flexible Benefits Package