Cyber Security Engineer - Medical Devices

Fusion Life Sciences Technologies LLC is focused on advancing medical device technology, and they are seeking a Cyber Security Engineer to ensure compliance with FDA cybersecurity guidance and IEC standards. The role involves conducting gap assessments, developing cybersecurity documentation, and integrating controls into risk management processes.

Responsibilities:

• Perform threat modeling, vulnerability assessments, and risk analyses specific to the device’s connected or software-enabled features
• Develop or update cybersecurity requirements and design controls documentation
• Support creation of cybersecurity verification test protocols and penetration testing strategies
• Integrate cybersecurity controls into the overall device risk management file
• Prepare cybersecurity risk management reports and Design Transfer documentation for manufacturing security controls

Requirements:

• Degree in Cybersecurity, Computer Engineering, or related field
• Medical device cybersecurity experience under FDA guidance
• Expertise in threat modeling (e.g. STRIDE), secure software development lifecycle, and penetration testing
• Knowledge of IEC 62304, ISO 14971, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, and AAMI SW96
• Experience in cybersecurity gap remediation for medical devices
• CISSP, CISM, or equivalent certification