Senior Verification Engineer
Senior Verification Engineer
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1 Vacancy
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.
- 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.
- Bachelors 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.
- Medical class II or class III is a must.
- Strong communication and presentation skills is a must.
- IEC medical standards is a must.
Employment Type
Full-time
