Remote Position
Medical Device Cybersecurity Engineer
🌍 Remote · United States
💼 Full-time
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