Director, Software Engineering

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.

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.

Qualifications

• 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.