COMPANY & JOB OVERVIEW:

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.
The Principal Software Engineer will be responsible for architecting, designing, developing, and maintaining user interface(s), user experience, and application software for our medical devices. This role will be required to work with cross-functional teams — including systems, hardware, regulatory experts, and clinical specialists to ensure that our software solutions meet the highest standards of quality, safety, and performance.

QUALIFICATIONS & REQUIREMENTS:

• Bachelor’s or Master’s degree in Computer Science, Computer Engineering, Electrical Engineering, or a related field.
• 8+ years of professional experience in software development, preferably in the medical device industry or other regulated environments; experience with embedded Linux platforms is strongly desired.
• Demonstrated expertise in designing sophisticated user interfaces and user experiences.
• Proficient in modern GUI development using C++, Qt, and QML, with strong programming experience in Python and test automation.
• Experience in customizing and configuring Embedded Linux development using Yocto build systems.
• Proficient with unit testing frameworks and UI automation tools.
• Familiarity with code quality tools and static code analysis to support best-in-class development practices.
• Solid knowledge of software architecture, design patterns, Object-Oriented Design/Programming, algorithms, data structures and SOLID principles.
• Experience with DevOps practices (e.g., CI/CD, and version control tools).
• Experience working in Agile/Scrum, V-model environments.
• Knowledge and working experience with IEC 62304, ISO 14971 (risk management).
• Experience with secure software design, cybersecurity principles, and architecting device data pipelines with cloud connectivity is a plus.
• Experience with communication protocols (I2C, SPI, UART, CAN, etc.)
• Excellent communication skills, with the ability to clearly articulate complex technical concepts.
• Possesses the ability to thrive in a fast-paced environment.
• Tools & Technologies: Qt, QML, C/C++, Python, Git, Yocto, Squish Qt, Squish Coco, SonarQube, Linux, Jama, Bitbucket, JIRA.

• Contributes to the development of company objectives and principles to achieve goals in creative and effective ways.
• Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.
• Recognized internally as a subject matter expert for UI/UX development, providing technical mentorship and guidance to junior engineers.
• Architect, design, develop and debug user interface and application software for embedded or connected medical device platforms.
• Work independently in team settings to deliver high-quality, testable, maintainable code that meets functional and safety requirements.
• Develop and maintain documents for compliance with FDA regulations for software safety Class B and Class C medical device software.
• Drive the use of design patterns and modern software architecture best practices in UI development with minimal impact to current design and project schedule.
• Support and drive participation in Agile development cycles, including sprint planning, story grooming, reviews, and retrospectives, within a Hybrid Agile-V model.