Director, Software Engineering

Job summary

Description: Company & Job Overview Dia*** is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Dia*** 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.

Qualifications

• Provide oversight for software lifecycle activities including
• 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
• and company quality system
• 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
• Required
• 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

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
• as assigned
• 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.
• Travel

Skills

Degrees

Travel

Industry

Company size

Contract length