Senior Automation Engineer

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