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.

KEY RESPONSIBILITIES

• 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.

ESSENTIAL SKILLS/EXPERIENCE

• 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.

PREFERRED REQUIREMENTS

• 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.

Seniority Level

Director

Employment Type

Full‑time

Job Function

Medical Equipment Manufacturing

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