Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 1 Year(s)
Skills
Regulatory Compliance
Research and Development
Risk Management
Presentations
Quality Assurance
Regulatory Affairs
Test Cases
Testing
Traceability Matrix
Verification And Validation
Web Applications
Web Testing
Workflow
Writing
Analytical Skill
Biomedical Engineering
Collaboration
Communication
Computer Science
Documentation
JIRA
Management
Medical Devices
PTC
Regression Analysis
Job Details
Position- Senior Verification Engineer - 4 Positions
Location: Pleasanton, CA (Day 1 onsite. Locals will be proffered)
Client-Abbott
Job Summary:
Manual Protocol Tester to support 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.
Medical class II or class III is a must
Strong communication and presentation skills is a must
IEC medical standards is a must
Key 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-level testing based on approved protocols.
- Develop and maintain test cases using tools like PTC or equivalent.
- 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.
Required Qualifications:
- 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 is plus.
- 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.
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