About the job
Roles & Responsibilities:
We are looking for a meticulous Verification and Validation (V&V) Engineer with over 3 years of experience in testing software and firmware for medical devices. This role entails the verification and validation of embedded systems utilized in medical technology, ensuring strict adherence to regulatory standards and product quality criteria.
The position encompasses test design, execution, automation, defect analysis, and regulatory documentation within a highly regulated setting.
Key Responsibilities:
Embedded Software Verification & Validation:
Craft and develop verification and validation test plans, protocols, and reports for embedded systems.
Conduct unit, integration, system, and regression testing for embedded firmware.
Carry out manual and automated testing of embedded medical device software.
Test Development & Automation:
Create automated test scripts using Python, C, or C++ or relevant test frameworks.
Establish and maintain test benches, hardware setups, and simulation environments.
Implement continuous testing within CI/CD frameworks.
Compliance & Documentation:
Assure compliance with medical device regulatory standards such as:
U.S. Food and Drug Administration (FDA) guidelines
IEC 62304 Medical Device Software Lifecycle Standard
ISO 13485 Quality Management System Standard
ISO 14971 Risk Management Standard
Prepare traceability matrices, validation reports, and defect documentation.
Collaboration:
Collaborate closely with embedded developers, system engineers, hardware teams, and quality engineers.
Engage in design reviews, risk assessments, and root cause analysis.
Defect Management:
Document and track defects using tools like JIRA, Polarion, or similar ALM tools.
Perform failure analysis and debugging in conjunction with developers.