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Manual Test Engineer

Accepting applications

Intellias · Newton, MA

Full-Time Mid_senior I2CPythonSPIaiasic
Posted
4 May
Category
Test
Experience
Mid_senior
Country
United States
Manual Test Engineer 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 Manual Test Engineer 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.

Requirements:
Technical Skills
5+ 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.

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
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