System Validation Engineer

Position : System Testing Engineer

Location : Mysore

Experience : 7+ Years

Role Overview :

We are seeking an experienced System Testing Engineer with a strong understanding of system architecture, hardware-software integration, and embedded systems testing. The ideal candidate will have experience in the medical domain , a solid grasp of regulatory standards, and the ability to work across cross-functional teams to ensure product quality and compliance.

Key Responsibilities :

• Analyze and understand system architecture, design, and both software and hardware components.
• Perform hands-on embedded systems testing , preferably in the medical device domain .
• Validate system performance, reliability, and functionality across the full product lifecycle.
• Support system integration activities and ensure compatibility across subsystems.
• Conduct system-level risk assessments and contribute to design improvements.
• Lead and support system verification and validation efforts, including test planning, execution, and traceability.
• Participate in system design and requirement reviews , and assist in troubleshooting and issue resolution.
• Monitor system performance against defined KPIs and customer expectations.
• Ensure design compliance with regulatory, safety, and industry standards .
• Develop comprehensive test cases, including methodology, setup, equipment, procedures, and acceptance criteria based on requirement analysis.
• Apply knowledge of medical device standards such as ISO 13485, ISO 14971, FDA, CE, and relevant IEC standards.
• Utilize tools such as JAMA, JIRA, ALM, Polarion , or similar platforms for test management and documentation.
• Collaborate effectively with cross-functional teams in a fast-paced development environment.
• Communicate technical concepts clearly and effectively.
• Support design transfer and sustenance engineering change reviews .