Cyber Security Engineer

Fusion Life Sciences Technologies LLC is focused on ensuring cybersecurity within medical devices. The Cybersecurity Engineer will conduct gap assessments and remediation for cybersecurity elements, ensuring compliance with FDA guidance and IEC standards.

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