Medical Device Software Engineer Jobs in Irvine, CA

Description

Company & Job Overview

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 Director of Software Engineering reports to Director of Product Development and leads Diality's Software Engineering and Software Verification & Validation organizations. This role serves as the functional leader for software development and software V&V activities while partnering closely with Systems Engineering, Hardware Engineering, Product Management, and other cross-functional organizations to support successful product development and lifecycle management.

The Director of Software Engineering is responsible for establishing software engineering strategy, developing high-performing organizations, guiding execution across multiple product lines, and partnering with cross-functional leaders to deliver innovative medical device solutions. The ideal candidate brings strong medical device software leadership experience, familiarity with Agile software development methodologies and V-Model SDLC, and a proven ability to build scalable engineering organizations that consistently deliver high-quality software.

Responsibilities

• Lead and develop Software Engineering and Software Verification & Validation organizations supporting new product development, sustaining engineering, and connected medical device software systems.
• Define and execute software engineering strategy, architecture direction, staffing and resource plans, and development priorities aligned with company objectives, product roadmaps, and regulatory requirements.
• Establish and continuously improve software development processes utilizing Hybrid Agile methodologies and V-Model SDLC while driving execution excellence, delivery predictability, engineering metrics, and continuous improvement.
• Provide oversight for software lifecycle activities including requirements management, architecture, implementation, integration, verification, validation, release management, sustaining engineering, and post-market software support.
• Ensure software development and verification activities comply with applicable medical device regulations, standards, design controls, cybersecurity requirements, and company quality system requirements.
• Partner with cross-functional leaders across Systems, Hardware, Product, Quality, Regulatory, Clinical, Manufacturing, Service, and Operations to support product development, product support, audits, inspections, and regulatory submissions.
• Manage software organizations, employees, contractors, offshore development teams, consultants, vendors, and external development partners while fostering accountability, ownership, collaboration, innovation, and quality.
• Recruit, develop, mentor, and retain high-performing engineering leaders and technical staff while building a strong engineering culture focused on accountability, innovation, collaboration, and continuous improvement.
• Performs other duties as assigned

Requirements

• Demonstrated strong leadership experience managing Software Engineering and Software Verification & Validation organizations in regulated product development environments. 
• Deep understanding of embedded software development, software architecture, complex system design, software verification, system integration, software quality practices, and medical device software lifecycle processes. 
• Hands on experience with Object-Oriented Design principles, embedded software development, C/C++, Python, Linux-based systems, BSP, bare-metal hardware/software integration, software debugging, and software lifecycle tools such as Jira, Jama, or equivalent platforms. 
• Experience leading software organizations utilizing Agile, Scrum, or V-Model, including practical sprint planning, execution, requirements traceability, risk management, verification, validation, and release processes. 
• Experience establishing and overseeing software development processes, engineering practices, and development organizations within regulated product development environments. 
• Experience with medical device software cybersecurity activities, including secure software development practices, threat modeling, vulnerability management, cybersecurity risk management, and regulatory compliance. 
• Ability to lead software organizations and deliver results in fast-paced, dynamic product development environments with evolving priorities and aggressive timelines. 
• Strong strategic thinking, leadership, communication, organizational, and stakeholder management skills with experience leading software organizations and external software engineer contractors. 
• Familiarity with cloud-connected medical device systems, mobile applications, interoperability, healthcare data platforms, and device-to-cloud communication architectures is a plus. 
• Strong understanding of IEC 62304, ISO 14971, FDA software validation expectations, medical device cybersecurity guidance, and design controls.

• Bachelor's or Master's degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or a related technical discipline.
• 15+ years of software engineering experience with progressively increasing technical and leadership responsibilities, including significant experience in regulated product development environments.
• Minimum of 7 years of formal leadership experience managing software engineering teams.
• Experience leading software development for complex embedded electromechanical systems within medical device industry
• Experience developing embedded software for hemodialysis systems or other complex Class II or Class III medical devices is highly preferred. 
• Demonstrated success leading Software Engineering and Software Verification & Validation organizations supporting both new product development and sustaining engineering activities.
• Proven track record delivering complex embedded medical device products from concept through verification, validation, regulatory clearance, manufacturing release, commercialization, and post-market support.
• Experience building and managing high-performing software organizations utilizing employees, contractors, offshore development teams, and external development partners.
• Experience supporting FDA submissions, audits, inspections, design controls, and software lifecycle compliance activities for Class II or Class III medical devices.

• Ability to travel (domestic and international) as required, approximately 10%

• Prolonged periods of sitting at a desk and working on a computer
• May be expected to lift 15 pounds at times