Software Verification Engineer

Hi

Title : Software Verification Engineer (Non -Clinical) - Must to have : Python ,C#

Location Palo Alto, CA

Key Responsibilities

Test Planning and Design

• 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

Education- Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

Experience

• 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).

Skills and Competencies

• 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, C#) for test automation.
• Good communication and teamwork skills

Regards

Sai