Senior Validation Engineer

About the Company
At Intellias, where technology takes center stage, people always come before processes. By creating a comfortable atmosphere in our team, we empower individuals to unlock their true potential and achieve extraordinary results. That’s why we offer a range of benefits that support your well-being and charge your professional growth.


About the Role
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.


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

Qualifications
5+ years experience in manual testing of embedded or hardware-integrated systems


Required Skills
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
Preferred Skills
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, EC 62304, and ISO 13485
Experience contributing to Design History File (DHF) documentation and audit readiness.

Equal Opportunity Statement
We are committed to fostering equity, diversity, and inclusion as an equal opportunity employer. All applicants will be considered for employment without discrimination based on race, color, religion, age, gender, nationality, disability, sexual orientation, gender identity or expression, veteran status, or any other characteristic protected by applicable law. We welcome and celebrate the uniqueness of every individual. Join Intellias for a career where your perspectives and contributions are vital to our shared success.
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