QA/Verification Engineer (Medical Device Software)

Overview

On Site
$60 - $65
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 12 Month(s)

Skills

Manual protocol-based testing
Medical device software verification
Medical Class II/III device experience
IEC medical standards
Selenium automation
Web application testing
Protocol writing and execution
Test documentation and reporting
Requirements traceability
Defect management (JIRA or equivalent)
Test case management (PTC or equivalent)
FDA compliance

Job Details

Key Responsibilities:

8+Years Experience

Manual Protocol and Automation 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.
  • Design and implement 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.
  • 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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