Degree in Cybersecurity, Computer Engineering, or related field; CISSP, CISM, or equivalent certification preferred.
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.
Requirements:
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.
Job description
This is a remote position.
The Cybersecurity Engineer will conduct targeted gap assessments and remediation for cybersecurity elements within Design Inputs, Design Outputs, V&V, and Risk Management, ensuring the medical device meets FDA cybersecurity guidance and IEC 81001-5-1 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.
Qualifications
Degree in Cybersecurity, Computer Engineering, or related field; CISSP, CISM, or equivalent certification preferred.
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.
