Senior Validation Engineer

Intellias; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

Intellias is seeking a Manual Test Engineer based in Minneapolis, Minnesota, responsible for the verification and validation of embedded medical systems. Candidates should have 5+ years of experience in manual testing, with a strong understanding of software testing and system integration. Responsibilities include designing and executing test cases, maintaining compliance with medical device standards, and collaborating with development teams. Knowledge of communication protocols and testing techniques is preferred. The role offers a chance to work in a diverse and inclusive environment.

Qualifications

• 5+ years experience in manual testing of embedded or hardware-integrated systems.
• Strong understanding of software testing fundamentals and system integration testing.
• Familiarity with embedded environments (Linux/RTOS is a plus).

Responsibilities

• Design, develop, and execute manual test cases and procedures.
• Perform functional, integration, and system-level testing.
• Maintain traceability between requirements and test coverage.

Skills

Software testing fundamentals

System and integration testing

Tools

UART

SPI

I2C

Job description

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

• 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
• Verification procedures
• Maintain traceability between requirements and test coverage
• Document results in compliance with medical device standards and audit requirements
• 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.