Source description
About the role
Position: Sr. Automation Engineer Location: Pleasanton, CA (Day 1 Onsite )
Experience: 8 - 10 Years
NOTE: Local candidates preferred
Overview
We are seeking a highly skilled Senior Automation Engineer with a strong software background to support software verification activities for web-based applications integrated with heart failure and medical devices. The ideal candidate will bring expertise in both manual protocol-based testing and automation, along with experience in medical device software verification and compliance with regulatory standards.
Key Responsibilities
Execute manual, protocol-based testing for web applications supporting heart failure device workflows.
Design, develop, and maintain Selenium-based automation scripts to validate web application functionality.
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.
Create and manage test cases using PTC or equivalent tools .
Document and track defects using JIRA or equivalent tools .
Ensure traceability between requirements, protocols, and test results.
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Regulatory Affairs.
Support Verification & Validation (V&V) activities and contribute to Design History File (DHF) documentation.
Ensure all testing activities comply with FDA and IEC medical standards .
Required Qualifications
Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or a related field.
8+ years of experience in software testing, with at least 5+ years in manual protocol-based testing within the medical device industry.
Hands-on experience with medical device software verification (Class II or Class III devices required).
Strong knowledge of web application testing and clinical workflows related to heart failure management .
Experience with protocol writing, execution, and compliance documentation in a regulated environment .
Familiarity with regression analysis, risk management, traceability matrices, and compliance documentation.
Proficiency in Selenium, JIRA, PTC (or equivalent tools) .
Strong communication, presentation, and analytical skills .
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