Medical Device Tester- Systems Verification Engineer

As a Systems Verification Engineer, you will be responsible for the overall system verification of connected health systems, mobile platforms, and non-implantable devices. Perform system test activities, collaborate with cross-functional teams to ensure robust integration & system tests to comply with regulatory standards, including ISO 13485 (Medical Devices) and ISO 14971 (Risk Management). More so, you will be encouraged to provide innovative ideas towards product, processes, and productivity improvements and contribute towards realizing them.

• Analyze and understand High Level & Low Level Design documents, Intended Use documents, Software Requirements.
• Analyze software requirements to provide timely and meaningful review feedback for testability, completeness, and consistency
• Design high level test scenarios or test considerations.
• Design system verification test cases at Integration & System level. End to End workflow & Functional tests to uncover bugs.
• Ensure requirement-test traceability and coverage.
• Estimate, Prioritize, Plan and Co-ordinate testing activities including test planning, test execution, test reporting & monitoring.
• Identify, record, Report and document defects/bugs in bug tracking tool.
• Work closely with SW team on bug fixing and improving overall product quality.
• Perform risk-based tests & Impact based tests to ensure optimal regression suites for product releases.
• Provide triage assistance when required to support faster analysis of bugs
• Coordinate with required stakeholders and teams to resolve any dependencies or impediments for testing.
• Ensure all verification and validation activities comply with ISO 13485 (Medical Devices) and ISO 14971 (Risk Management) standards.
• Bachelor’s / Master’s degree in Computer Science, Electrical Engineering, or related field (or equivalent experience).
• 8+ years of experience in System Verification & Validation (Product testing), systems engineering, with significant exposure to medical devices or regulated environments.
• Deep knowledge of medical products/systems, performance testing, and troubleshooting.
• Strong experience with mobile application testing (Android/iOS) and system integration & system testing.
• Proficiency in requirements analysis, configuration management, and issue tracking systems (Jira, Git, etc.).
• Excellent analytical, problem-solving, and communication skills.
• Proven ability to collaborate with teams across different regions.
• Test automation using Appium, Python, Selenium, API Automation and related tools (Optional).
• Good knowledge of AI tools.
• Excellent analytical skills coupled with a high level of initiative and responsibility
• Eagerness to take on responsibility and natural curiosity to creatively search for software defects
• Ability to effectively execute in a complex, high-pressure environment
• Ability to conform to shifting priorities, demands and timelines
• Proven ability to work in a dynamic, multi-disciplinary team environment
• Proven relationship building skills
• Team player with excellent interpersonal and verbal

Education: Master Of Engineering,Master Of Technology,MCA,MSc,Bachelor of Engineering,Bachelor Of Technology,BCA,BSc

• Preferred skills: Technology->Performance Testing->Performance Testing
• ALL->Rational Performance Tester,Domain->Healthcare->Healthcare
• ALL,Domain->Healthcare->Equipment & Systems,Technology->Embedded Software->Medical Devices,Domain->Product Management->Product Management
• All->Medical Devices,Technology->Functional Testing->Functional Testing
• ALL,Technology->Mobile Testing->Mobile Testing
• ALL,Technology->Quality models/improvement frameworks->ISO 13485->ISO 13485 Quality manual and associated processes