Cybersecurity Software Engineer

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

📋 Description

• Integrate cybersecurity needs into the design and development of software for diagnostic platforms (coding on embedded software).

• Ensure adherence to FDA cybersecurity guidelines (both pre-market and post-market) and relevant North American regulations.

• Collaborate with software development teams to guarantee secure-by-design implementation.

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

• Contribute to and uphold Design History File (DHF) documentation in accordance with design control requirements.

• Support software lifecycle activities aligned with IEC 62304 standards.

• Engage in risk management activities as per ISO 14971 (e.g., threat modeling, risk analysis, and mitigation strategies).

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

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

⛳️ Requirements

• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, or a similar field.

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

• Recent experience in cybersecurity, ideally within the medical device or another regulated industry.

• Strong comprehension 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 (e.g., DHF, technical files).

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

• Experience in Software and Hardware integration.

• Strong collaboration and communication skills with stakeholders.

• Familiarity with threat modeling, vulnerability assessment, or security risk management.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options