Medical Device Cybersecurity Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Integrate cybersecurity specifications into the software design and development process for diagnostic platforms, including programming for embedded software.

• Ensure adherence to FDA cybersecurity guidelines and relevant North American regulations.

• Collaborate with software development teams to implement secure-by-design practices.

• Convert cybersecurity and regulatory requirements into technical specifications and documentation.

• Assist in the creation and maintenance of Design History File (DHF) documentation in accordance with design control requirements.

• Support software lifecycle activities in alignment with IEC 62304 standards.

• Engage in ISO 14971 risk management processes, including threat modeling, risk analysis, and mitigation strategies.

• Review system architecture and design to ensure compliance with secure development principles.

• Act as a cross-functional liaison among R&D, Quality, Regulatory, and Software Engineering teams.

• Undertake additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, or a related discipline.

• 5 years of experience in software engineering or system-level positions.

• Recent experience in cybersecurity, ideally within the medical device or other regulated sectors.

• Strong knowledge of FDA cybersecurity guidance (both pre-market and post-market).

• Familiarity with IEC 62304 software lifecycle processes.

• Knowledge of ISO 14971 risk management principles.

• Experience with regulated design documentation, such as DHF and technical files.

• Capacity to interpret and convey complex technical and regulatory requirements across multidisciplinary teams.

• Experience in software and hardware integration.

• Experience in threat modeling, vulnerability assessment, or security risk management.

• Preferred: experience in a Software Lead or Technical Lead role.

• Preferred: knowledge of Laboratory Information Systems (LIS) and remote device management (IoT).

• Preferred: understanding of AAMI TIR57/TIR97, IEC 81001-5-1, NIST Cybersecurity Framework, or OWASP.

• Basic proficiency in French or Korean is preferred.

🏝️ Benefits

• International travel ranging from 10–15%.

• Equal employment opportunity consideration for qualified candidates.