Cybersecurity Engineer

Cybersecurity Engineer

Spectral AI, Inc. (Spectral) is seeking a Cybersecurity Engineer to join our growing design and development team. The position is based in Dallas, Texas, with hybrid work flexibility in accordance with the Spectral Employee Handbook guidelines. The Cyber Security Engineer will support the design, development, and maintenance of secure medical device software systems, ensuring that cybersecurity controls are resilient and compliant with FDA regulations, international standards, and organizational security policies. The engineer will collaborate closely with Software Engineering, Hardware Engineering, Quality Assurance, Regulatory Affairs, Biomedical Engineering, Data Science, Systems Engineering, and IT internal teams to embed cybersecurity into design controls, risk management, regulatory submissions, and post-market surveillance activities.

Essential Duties and Responsibilities:

• Institute Security-by-Design practices throughout the entire lifecycle of the Spectral device software, AI models, firmware, and hardware.
• Develop and maintain cybersecurity standard operating procedures (SOPs) and work instructions that support compliance with regulatory and security requirements in all target markets for Spectral products.
• Support design reviews by providing security input and ensuring cybersecurity is integrated into design controls.
• Perform cybersecurity risk assessments for medical device systems using structured methodologies.
• Execute and document risk evaluation aligned with FDA Premarket Cybersecurity Guidance and ISO 14971.
• Participate actively in Coordinated Vulnerability Disclosure (CVD) processes.
• Maintain and periodically update cybersecurity documentation and supporting artifacts.
• Collaborate with software engineers to implement secure coding practices.
• Ensure correct implementation of security requirements, encryption standards, authentication and authorization controls, and security-relevant logging.
• Evaluate SOUP/OTS components for vulnerabilities.
• Perform vulnerability scanning across firmware, software, cloud services, Linux-based, and Windows-based cart devices.
• Prepare documentation, architecture diagrams, and accounts for test execution.
• Assist in establishing cybersecurity monitoring processes.

Qualifications:

Required education and experience:

• Bachelor's degree or above in Computer Science, Cybersecurity, Electrical/Computer Engineering, or a related field.
• 3–5 years of proven experience in cybersecurity engineering, ideally within medical devices, healthcare technology, regulated software, or other safety-critical systems.
• Demonstrated proficiency in technical writing.

Knowledge, Skills and Abilities:

• FDA Premarket Cybersecurity Guidance
• IEC 62304 Software Lifecycle
• AAMI TIR57 / TIR97
• OWASP Top 10, CWE, and secure coding principles
• Familiarity with Transport Layer Security (TLS), certificate management, encryption protocols, and authentication/authorization models.
• Understanding of cybersecurity vulnerabilities and FDA reporting requirements
• Understanding of Windows and Linux OS hardening, cloud security, and secure configuration.

Preferred Qualifications:

• Experience supporting FDA medical device submissions with cybersecurity documentation.
• Hands-on experience with medical cart or handheld device security.
• Experience with cloud-connected medical systems.
• Certifications such as Security+, CySA+, CISSP, GSEC, CEH, or industry equivalent.

Soft Skills:

• Excellent written and verbal communication skills in English.
• Detail-oriented, strong analytical and problem-solving skills.
• Ability to prepare quality cybersecurity documentation suitable for regulatory review.
• Ability to collaborate across functional teams.
• Comfortable managing multiple concurrent security tasks.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.

Travel:

Occasional support during off-hours for security events or release deadlines

Equal Employment Opportunity:

Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws.