Job Description:
• Integrate cybersecurity requirements into software design and development for diagnostic platforms, including coding on embedded software
• Ensure compliance with FDA cybersecurity guidance and applicable North American regulations
• Collaborate with software development teams on secure-by-design implementation
• Translate cybersecurity and regulatory requirements into technical specifications and documentation
• Contribute to and maintain Design History File (DHF) documentation under design control requirements
• Support software lifecycle activities aligned with IEC 62304
• Participate in ISO 14971 risk management activities, including threat modeling, risk analysis, and mitigation strategies
• Review system architecture and design for secure development principles
• Serve as a cross-functional liaison between R&D, Quality, Regulatory, and Software Engineering teams
• Perform other duties as assigned
Requirements:
• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, or related field
• 5 years of experience in software engineering or system-level roles
• Recent experience in cybersecurity, preferably within the medical device or other regulated industry
• Strong understanding of FDA cybersecurity guidance (pre-market and post-market)
• Understanding of IEC 62304 software lifecycle processes
• Understanding of ISO 14971 risk management principles
• Experience working with regulated design documentation, such as DHF and technical files
• Ability to interpret and communicate complex technical and regulatory requirements across multidisciplinary teams
• Experience with software and hardware integration
• Experience with threat modeling, vulnerability assessment, or security risk management
• Preferred: experience as a Software Lead or Technical Lead
• Preferred: familiarity with Laboratory Information Systems (LIS) and remote device management (IoT)
• Preferred: knowledge of AAMI TIR57/TIR97, IEC 81001-5-1, NIST Cybersecurity Framework, or OWASP
• Basic knowledge of French or Korean language preferred
Benefits:
• International travel at 10–15%
• Equal employment opportunity consideration for qualified applicants