Head of Software Engineering

JOB PURPOSE

We are seeking an experienced and technically exceptional Head of Software/Chief Architect to lead the software architecture, development, and verification activities for the new model. This role is mission critical and collaborate with the entire software team and quality team.

• Architect and lead the development of a modular, fault-tolerant robotics software platform. Ensure the design is scalable, maintainable, and safety-critical to meet the demands of a class C medical device.
• Ensure that all software development processes and outputs comply with relevant medical device standards and regulations, including IEC 62304 (Class
  
  C), ISO 14971, and ISO 13485
  .
• Lead the software verification and validation efforts, overseeing the creation of detailed documentation and traceability artifacts. This includes software requirements, design specifications, risk analysis, test plans/results, and traceability matrices.
• Collaborate closely with our software engineering team in Korea to integrate development efforts and liaise with US-based leadership (VP of Robotics).
• Work cross-functionally with hardware, regulatory, and clinical teams to ensure seamless integration of the software with robotic hardware and embedded subsystems.
• Ensure the software platform integrates with validated, safety-certified real-time operating systems and implement robust field upgrade mechanisms.
• Provide technical mentorship and guidance to the software team in secure software development and cybersecurity best practices. Drive technical excellence through code reviews, design discussions, and continuous improvement initiatives, fostering a culture of quality and innovation without direct managerial authority.

• 10+ years of experience in medical device software environments.
• Deep understanding of IEC 62304, ISO 14971, ISO 13485, and FDA software validation processes.
• Proven ability to design and implement robust software architecture for complex systems. Understanding of field upgrade frameworks, version control, and rollback strategies in regulated environments.
• Demonstrated leadership in secure software development, cybersecurity lifecycle integration, and compliance with latest FDA guidance.
• Excellent communication, documentation, and cross-disciplinary collaboration skills.

• Strong hands‑on experience with QNX 7.X, Linux RT.
• Proven success in building and maintaining unit/system-level tests within CI/CD pipelines.
• Direct experience developing Class II or III medical devices cleared via FDA 510(k), De Novo, or PMA.
• Previous involvement in IEC 62304 Class C software lifecycle projects with full traceability matrix ownership.
• Familiarity with IEC 13485, ISO 14971, and IEC 60601 integration in software development workflows.
• Experience with FDA pre‑submissions, Design History Files (DHF), and verification and validation test plans.
• Strong command of automated testing frameworks and code quality gates.
• Experience with secure software architecture, including secure boot, encrypted communication, and FDA‑aligned cybersecurity risk management.
• Familiarity with SBOM (Software Bill of Materials).
• Strong documentation, mentoring, and FDA audit preparation experience.

Director

Full‑time

Medical Equipment Manufacturing

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