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Senior Verification Engineer

Senior Verification Engineer

Katalyst HealthCares & Life SciencesPleasanton, CA
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Job Description :

  • Manual Protocol Tester to support software verification activities for web-based applications integrated with heart failure / medical devices.
  • The ideal candidate will have hands-on experience in protocol-based testing, medical device software verification, and compliance with regulatory standards.

Responsibilities :

  • Execute manual protocol-based testing for web applications supporting heart failure device workflows.
  • Review and validate software requirements, design specifications, and protocol documents.
  • Develop and maintain test protocols, test cases, and test reports in alignment with regulatory standards.
  • Perform functional, integration, regression, and system-level testing based on approved protocols.
  • Develop and maintain test cases using tools like PTC or equivalent.
  • Document and manage defects using tools like JIRA or equivalent.
  • Ensure traceability between requirements, protocols, and test results.
  • Collaborate with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs.
  • Support verification and validation (V&V) activities and contribute to design history file (DHF) documentation.
  • Ensure testing activities comply with FDA standards.

    • Requirements :

  • Bachelor's degree in engineering, Computer Science, Biomedical Engineering, or related field.
  • Minimum years of experience in manual protocol-based testing and within the medical device industry is plus.
  • Strong understanding of web application testing and clinical workflows related to heart failure management.
  • Experience with protocol writing, execution, and documentation in a regulated environment.
  • Familiarity with regression analysis, risk management, traceability matrices, and compliance documentation.
  • Excellent communication and analytical skills.
  • Medical class II or class III is a must.
  • Strong communication and presentation skills is a must.
  • IEC medical standards is a must.
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    Verification Engineer • Pleasanton, CA