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Senior Verification Engineer

Senior Verification Engineer

cGxPServePleasanton, California, USA
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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 :

  • Bachelors degree in engineering Computer Science Biomedical Engineering or related field.
  • Minimum 5 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.

    • Key Skills

    Apache Web Server,C++,Community Support,Bakery,Islamic Banking

    Employment Type : Full-time

    Experience : years

    Vacancy : 1

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    Verification Engineer • Pleasanton, California, USA