Qualifications:
Education: Minimum of a Bachelor's degree in Computer Science, Engineering, or a related field is required; MS or advanced degree is preferred.
Experience: A minimum of 5 years in security and/or embedded software engineering functions, with a focus on product security in regulated environments (medical devices is a plus).
Technical Skills:
Understanding of threat modeling, and vulnerability management.
Experience with vulnerability scanning, penetration testing, and risk assessment tools (CVSS, OWASP, etc.).
Knowledge of Software Bill of Materials (SBOM) and how it relates to security and compliance.
Security & Regulatory Expertise:
Understanding of medical device security requirements, including FDA regulations, 510k submissions, and Quality Design Control processes.
Familiarity with threat modeling, risk management frameworks, and vulnerability management for medical devices.
Communication & Leadership Skills:
Strong interpersonal and collaboration skills with the ability to communicate complex technical concepts to non-technical stakeholders.
Proven ability to influence cross-functional teams to drive security improvements and achieve desired outcomes.
Experience creating and presenting security metrics and reports to senior management
Certifications (preferred, not required):
CISSP, CEH, MCSD, CSSLP, or similar security certification
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