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