Director, Software Engineering

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