Software Verification Engineer (Clinical) - Katalyst Healthcares & Life Sciences
Palo Alto, CA 94020
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences