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 .