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 Senior Software Engineer will be responsible for designing, developing, testing, and maintaining embedded software, and related tools for our medical devices. This role requires effective collaboration with cross-functional team members including systems, hardware, regulatory, and clinical staff to ensure the software aligns with product requirements and complies with safety, performance, and usability standards.

Responsibilities

• Design, implement, debug, and test embedded software for Class B and Class C medical devices using C/C++ and Python.
• Deliver high-quality, testable, and maintainable code that meets functional, performance, and safety requirements.
• Ensure embedded software design robustness through unit testing, static analysis, code reviews, and integration testing.
• Work closely with electrical, mechanical, systems, and software teams to define embedded software interfaces and system-level behaviors.
• Support board bring-up, device integration, and hardware-software co-design activities.
• Participate in software development within a Hybrid Agile-V model, contributing to sprint planning, grooming, reviews, and retrospectives.
• Create and maintain requirements, design, implementation, and verification documentation in accordance with FDA regulations and IEC 62304 standard.
• Operate effectively both independently and as a collaborative team member in a fast-paced, dynamic development environment.

Required Skills & Abilities

• Proficient in embedded C/C++ programming with working knowledge of Python for scripting test and automation tasks.
• Solid understanding of real-time operating systems (RTOS), interrupt handling, memory management, and hardware abstraction.
• Skilled in device driver development. The ability to read and interpret hardware data sheets and schematics is a plus.
• Expertise in debugging and troubleshooting, using tools such as debuggers, oscilloscopes, logic analyzers, and JTAG/SWD interfaces.
• Familiarity with closed-loop control and PID algorithms is a plus.
• Strong knowledge of software engineering principles including modular design, version control (e.g., Git), and continuous integration workflows.
• Familiarity with Agile development practices and hybrid Agile/V-Model processes.
• Excellent written and verbal communication skills, with the ability to produce clear technical documentation and collaborate across multidisciplinary teams.
• Self-motivated and adaptable with proven ability to work independently and as part of a team in a dynamic, fast-paced environment.

Education & Experience

• Bachelor’s or Master’s degree in Computer Science, Electrical Engineering, or a related field.
• 5+ years of professional software development experience, preferably in the medical device or regulated industry.
• Experience developing embedded software for microcontroller-based systems (e.g., STM32, NXP, TI) and working with communication protocols such as UART, SPI, I2C, and CAN.
• Experience with unit testing, static analysis, code reviews, and system integration testing in a structured SDLC environment.
• Practical experience developing and documenting embedded software for FDA-regulated Class B and Class C medical device software.
• Working knowledge of relevant standards including IEC 62304 (software life cycle), ISO 14971 (risk management), and FDA medical device software guidance.

Physical Requirements

Sustained periods of time standing and sitting in a laboratory

Sitting at a desk utilizing a computer

Some lifting of

Travel

• Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.