Job Description:

• 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.

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.

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 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.

• 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