Medical Device Test Engineer (Embedded Systems Test Engineer)

SARACA is a global engineering R&D services company specializing in innovative medical device design and development. The Medical Device Test Engineer will design, develop, and execute test cases for embedded systems, ensuring compliance with industry standards and quality of medical device software.

Responsibilities:

• Create & maintain test documentation aligned with FDA, IEC 62304, ISO 13485
• Design functional, integration, regression, and system-level test cases
• Define test coverage based on requirements and risk analysis
• Develop automated test scripts for embedded systems
• Build test environments & hardware/software simulation setups
• Ensure traceability (RTM) between requirements and test cases
• Participate in risk management & hazard analysis activities

Requirements:

• Bachelor's in CS / Electrical / Biomedical or related field
• 6+ years of experience in embedded software testing
• Strong experience in medical devices domain
• Knowledge of SDLC & V-Model
• Hands-on with FDA, IEC 62304, ISO 13485
• Experience with embedded debugging tools
• Automation experience (Python/C/C++)
• HIL / simulation testing
• Strong documentation & communication skills