Need submission details for Senior Verification Engineer, Pleasanton, CA, Onsite

Net2Source • Pleasanton, CA

3d • Onsite

About The Position

This is an urgent, long-term contract project for a Senior Verification Engineer. The role involves supporting 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. Experience with medical class II or class III devices, strong communication and presentation skills, and knowledge of IEC medical standards are essential.

Requirements

• Bachelor’s 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.
• 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 experience is a must.
• Strong communication and presentation skills is a must.
• IEC medical standards knowledge is a must.

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 testing.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior