Senior Consultant
Praecipio
GroovyITSMJavaScriptPythonSQLTableau
Enterprise Software Test Engineer II
Medtronic
full-time
Posted on:
Origin: • 🇮🇳 India
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
GroovyJavaSelenium
About the role
- 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.
Requirements
- A Bachelor’s degree in Computer science, Electrical, Electronics / equivalent from reputed institution.
- 4 to 8 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.
