Principal Manual Test Engineer Lead (Embedded)

The Principal Manual Test Engineer Lead is responsible for verification and validation of embedded medical systems, including execution of functional, integration, and system-level tests, analysis of hardware-software interactions, and documentation aligned with regulatory standards. Ensures product reliability and safety in a highly regulated healthcare environment.

We are looking for a Principal Manual Test Engineer Lead to join a team developing cutting-edge solutions in cardiac electrophysiology. You will collaborate with engineers building an integrated system that enables physicians to map, ablate, and monitor cardiac arrhythmias with high precision.

The role focuses on manual verification and validation of embedded systems , including hardware-software integration, ensuring reliability, safety, and performance of complex medical devices. You will design and execute test scenarios, analyze system behavior under real-world and edge conditions, and contribute to delivering faster, safer, and more effective treatment solutions. Experience with embedded systems is a strong advantage.

Responsibilities:

Manual Testing & Verification

• Design, develop, and execute manual test cases and test procedures based on system and software requirements
• Perform functional, integration, and system-level testing for embedded medical devices
• Execute regression, exploratory, and scenario-based testing to ensure robust product quality

Test Design & Documentation

• Translate requirements into:
• Test cases
• Test scenarios
• Verification procedures
• Maintain traceability between requirements and test coverage
• Document results in compliance with medical device standards and audit requirements

Defect Management & Analysis

• Identify, log, and track defects in defect management systems
• Analyze failures, reproduce issues, and provide root cause hypotheses
• Work closely with development teams to verify fixes and improvements

Embedded Systems & HW/SW Integration

• Validate interactions between:
• Embedded software (firmware)
• Hardware components (sensors, controllers, medical equipment)
• Perform testing in lab environments using real devices and simulators
• Work with communication interfaces (UART, SPI, I2C, etc.) and device-level diagnostics

Requirements:

Technical Skills

• 10+ years experience in manual testing of embedded or hardware-integrated systems
• Strong understanding of:
• Software testing fundamentals
• System and integration testing
• Familiarity with:
• Embedded environments (Linux/RTOS is a plus)
• Communication protocols (UART, SPI, I2C)
• Testing Expertise
• Requirements-based testing and traceability
• Test design techniques (boundary value, equivalence partitioning, exploratory testing)
• Experience in fault injection and edge-case validation
• Domain Knowledge (Preferred)
• Experience in medical devices or other safety-critical domains
• Understanding of risk-based testing and patient safety considerations

Will be a plus:

• Basic scripting or automation exposure (Python is a plus)
• Experience supporting verification activities in regulated environments, including familiarity with FDA guidelines , IEC 62304 , and ISO 13485
• Experience contributing to Design History File (DHF) documentation and audit readiness.