Medical Device Tester- Systems Verification Engineer

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  • Pune, Maharashtra
  • Permanent
  • Full-time
  • 15 days ago
Responsibilities :
  • 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.
Additional Responsibilities :
  • 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
Technical and Professional Requirements :
  • 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
Preferred Skills :Domain->Healthcare->Equipment & Systems,Domain->Healthcare->Healthcare - ALL,Technology->Performance Testing->Performance Testing - ALL->Rational Performance Tester,Technology->Quality models/improvement frameworks->ISO 13485->ISO 13485 Quality manual and associated processes,Technology->Functional Testing->Functional Testing - ALL,Technology->Mobile Testing->Mobile Testing - ALL,Technology->Embedded Software->Medical Devices,Domain->Product Management->Product Management - All->Medical DevicesEducational Requirements :Bachelor of Engineering,Bachelor Of Technology,BSc,BCA,Master Of Engineering,Master Of Technology,MSc,MCAService Line :Engineering Services

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