Test Architect

Role Summary: We are seeking an experienced and highly skilled Test Architect to join our dynamic team. The Test Architect will be responsible for defining and implementing comprehensive test strategies, methodologies, and frameworks for our medical device software and hardware products. This role requires a deep understanding of software quality assurance principles, test automation, and the specific regulatory requirements of the medical device industry.

Key Responsibilities:

• Develop and maintain a robust test architecture for medical device software and hardware.
• Define test strategies, test plans, and test cases aligned with product requirements and regulatory standards (e.g., IEC 62304, ISO 13485).
• Lead the design and implementation of automated testing frameworks and tools.
• Oversee the execution of various testing types, including functional, integration, system, performance, security, and usability testing.
• Collaborate with development, product management, and regulatory affairs teams to ensure product quality and compliance.
• Mentor and guide junior test engineers, fostering a culture of quality excellence.
• Identify and implement process improvements in testing methodologies and tools.
• Analyze test results, generate reports, and communicate findings to stakeholders.
• Ensure traceability between requirements, test cases, and test results.