Software Verification Engineer

3 weeks ago


La Honda, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team.
  • The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements.
  • This role involves designing, implementing, and executing test plans and procedures to identify and document software defects Regards.
  • Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications.
  • Ensure test plans cover all functional and non-functional requirements, including performance, reliability, and security.
  • Documentation and Reporting.
  • Document test results, including detailed descriptions of defects and steps to reproduce them.
  • Generate and maintain test reports, defect logs, and other documentation required for regulatory compliance.
  • Communicate test outcomes and defect status to development teams and management.
  • Collaboration Work closely with software developers, and systems engineers, to understand software requirements and functionality.
  • Compliance and Standards Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).
  • Stay updated with industry best practices and evolving regulatory requirements for medical device software.
Requirements:
  • Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
  • Minimum of 5+ years of experience in software testing, preferably in the medical device industry.
  • Experience with testing tools and frameworks (e.g., ClearQuest, Jama).
  • Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Strong understanding of software development and testing methodologies.
  • Excellent analytical and problem-solving skills. Attention to detail and a high level of accuracy.
  • Proficiency in scripting or programming languages (e.g., Python, Java, C#) for test automation.
  • Good communication and teamwork skills.


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