Senior Verification Engineer

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.