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 .
System Engineer • Pune, Maharashtra, India