Product Cybersecurity Engineer (Medical Devices)
Core
Lead cybersecurity activities across the medical device product lifecycle, ensuring security, privacy, and regulatory compliance for connected medical devices and Software as a Medical Device (SaMD) solutions.
Role type
Senior IC product cybersecurity engineer (medical devices)
Builds
Secure medical device products and SaMD solutions compliant with FDA regulations
Domain
Healthcare / Medical Devices / Cybersecurity
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
threat modeling, cybersecurity risk management, FDA regulatory compliance (510k), secure architecture review, vulnerability management, SBOM generation, secure development lifecycle (SDL), security testing, penetration testing, security requirements definition, incident response, supply chain cybersecurity
Preferred skills
post-market cybersecurity monitoring, cloud-connected platform security, AI/ML-enabled medical product security, professional certifications (CISSP, CSSLP, HCISPP, GICSP, Security+)
Technologies
STRIDE, attack trees, misuse cases, NIST Cybersecurity Framework, ISO 14971, IEC 62304, AAMI TIR57, OWASP
Responsibilities
Perform product security risk assessments and threat modeling for medical devices and SaMD platforms. Lead cybersecurity risk management activities throughout the product lifecycle in alignment with FDA guidance. Support cybersecurity documentation for FDA regulatory submissions, including cybersecurity risk management files and SBOM requirements. Conduct security architecture reviews and evaluate system designs against secure architecture principles. Develop and maintain cybersecurity risk management documentation, vulnerability management processes, and incident response procedures. Partner with internal and external teams to integrate secure-by-design principles into product development. Participate in secure development lifecycle (SDL/SSDLC) activities, including security requirements definition, design reviews, and cybersecurity verification activities. Analyze results from vulnerability assessments, static analysis, dynamic analysis, penetration testing, and security scanning activities. Investigate and support remediation of cybersecurity vulnerabilities affecting medical devices and connected product ecosystems. Support internal audits, external assessments, FDA inspections, and cybersecurity reviews. Serve as a cybersecurity subject matter expert (SME) for cross-functional teams.
Seniority
Senior, hands-on IC