Engineer II, Software Test

Danaher•Irvine, CA

6h•Onsite

About The Position

Masimo, a Danaher operating company, develops medical monitoring technologies, sensors, patient monitors, and automation and connectivity solutions. Its mission is to empower clinicians to transform patient care. The Engineer II, Software Test designs, develops, and executes test strategies for medical device systems, combining hands-on system-level testing with the creation of manual and automated test cases to ensure product quality, reliability, and regulatory compliance. This on-site position is in the Software Test Engineering department in Irvine, California, and reports to the Sr Manager, Instrument Software Test. The role collaborates with software, hardware, systems, and quality teams on test strategies and quality goals, and supports system integration, product bring-up, and troubleshooting.

Requirements

Bachelor of Science degree in computer science, computer engineering, software engineering, biomedical engineering, or a related technical discipline.
At least 3 years of experience in medical device testing, system validation, or software quality engineering.
Strong understanding of system-level testing across hardware, software, and integrated systems.
Hands-on experience with lab equipment and system-level debugging.
Experience with test automation frameworks and scripting using Python, C/C++, or similar.

Nice To Haves

Familiarity with IEC 62304, ISO 13485, FDA Quality System Regulation, or other applicable software quality standards.
Proficiency in industry-standard communication protocols, including RS-232, I²C, SPI, and TCP/IP, for hardware and software integration, debugging, and validation.
Strong analytical and problem-solving skills.

Responsibilities

Design and develop comprehensive test strategies, plans, and test cases for medical device systems.
Execute and oversee functional, integration, system-level, and performance testing.
Review requirements and system architecture to ensure testability and coverage.
Develop test reports, traceability matrices, and validation documentation.
Build automated test scripts using languages such as Python, TCL, or similar.
Partner with software, hardware, systems, and quality teams to define test strategies and quality goals.
Support system integration, product bring-up, and troubleshooting efforts.