Associate Director, Software Digital Health Solutions

Diality, Inc.; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Diality, Inc. is seeking an Associate Director of Software (Digital Health Solutions) to lead the development of cloud-based, connectable software for SaMD.

You will bridge technology and clinical impact, guiding architecture, AI integration, and regulatory compliance while partnering with device software, research, and product teams. This senior role requires a strong track record in cloud-enabled medical software, leadership of engineers, and a passion for improving patient care through

Qualifications

• Bachelor’s or Master’s degree in Software Engineering, Computer Science, or related field.
• 10+ years of software development experience, with 5+ years in leadership roles.
• Proven track record delivering SaMD and cloud-based healthcare software.
• Experience integrating AI/ML into clinical decision support systems.
• Familiarity with regulatory standards (FDA, HIPAA, IEC 62304).

Responsibilities

• Set the digital software strategy, roadmaps, and resourcing plans.
• Lead a team of engineers and cross-functional partners to execute.
• Collaborate with device software, research, product, and commercial teams.
• Ensure quality, regulatory compliance, and risk management across products.

Skills

AWS & Cloud Architecture

SaMD development

Cross-functional collaboration

AI/ML integration in software

Regulatory & compliance knowledge

Strong communication

Education

Bachelor’s or Master’s degree in Software Engineering or Computer Science

10+ years software development experience

Tools

EMR/EHR integration

Job description

Description

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Associate Director of Software, Digital Health Solutions, leads the development of digital products that support Diality’s vision: revolutionizing dialysis across every setting—empowering patients, inspiring innovation, and expanding access to care. This strategic role will bridge technology and clinical impact by building cloud-based solutions that leverage device data for a range of user types, through thoughtful execution and cross-functional collaboration.

Responsibilities

Leadership & Strategy

• Lead the definition and execution of Diality’s digital software strategy, including product roadmaps, foundational tools and infrastructure, and resourcing plans.


• Mentor and guide a team of engineers and partners, fostering a culture of innovation, collaboration, and continuous improvement.


• Identify, recruit, retain, and motivate key talent to support organizational goals.


• Collaborate cross-functionally with device software, systems, research, and product teams to align digital software development with the overall product strategy.


• Champion a culture that reflects Diality’s core values: Patient-Centric, Driven, Accountable, and Collaborative.

Technical Oversight

• Oversee architecture, design, prototyping, testing, verification and validation, and deployment of digital software products—including cloud, connectivity, mobile applications, and AI solutions.


• Ensure compliance with regulatory standards (e.g., FDA, HIPAA, IEC 62304) and industry best practices.


• Drive delivery of high-quality, reliable software solutions.

Project & Resource Management

• Oversee project schedules, budgets, and resource distribution to ensure timely achievement of development milestones.


• Optimize resourcing strategies based on business needs, including schedule, cost, and capabilities.


• Identify, evaluate, and manage external development partners.

Innovation & Continuous Improvement

• Identify and implement emerging technologies, tools, and processes to enhance digital software capabilities and accelerate development.


• Establish innovative, risk-aligned software development strategies tailored to product classification and clinical context.


• Promote a data-driven approach to decision-making, risk management, and continuous improvement.

Requirements

• Deep understanding of AWS and cloud architecture, mobile development, and embedded systems


• Proven track record in developing and deploying Software as a Medical Device (SaMD)


• Strong communication skills and a collaborative mindset


• Demonstrated ability to collaborate closely with cross-functional stakeholders—including clinical, product, and commercial teams—to assist in translating user needs and desired outcomes into intuitive, high-impact digital products and services


• Passion for improving lives through technology

Education & Experience

• Bachelor’s or Master’s degree in Software Engineering, Computer Science, or related field


• 10+ years of experience in software development, with 5+ years in leadership roles.


• Proven track record of delivering complex software systems in a medical device environment


• Experience with EMR/EHR integration preferred


• Hands‑on experience integrating AI and machine learning technologies into software solutions, with a focus on enhancing clinical decision support, predictive analytics, or personalized patient experiences


• Experience navigating ambiguity and aligning technical execution with strategic business goals

Travel

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

Physical Requirements

• Sustained periods of time standing and sitting in a laboratory


• Sitting at a desk utilizing a computer


• Some lifting of<25 pounds

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.