RCI-BDX-3647 Product Cybersecurity Engineer (Medical Device Cybersecurity/SaMD/FDA 510(k)/Threat Modeling/Vulnerability Assessment/NIST 800.ISO 13485/ISO 27001/AAMI TIR57)

Rangam is seeking a Product Security Engineer to support the security architecture and risk management activities for medical devices and Software as a Medical Device (SaMD) platforms. The role involves performing threat modeling, supporting cybersecurity documentation for FDA submissions, and collaborating with cross-functional teams to ensure regulatory compliance and security best practices.

Responsibilities:

• Perform product security risk assessments and threat modeling for medical devices and SaMD platforms
• Support cybersecurity documentation for FDA regulatory submissions including 510(k), cybersecurity risk management files, and SBOM requirements
• Conduct security architecture reviews for medical platforms
• Evaluate system designs against secure architecture principles, regulatory expectations, and cybersecurity frameworks
• Develop and maintain Product Security Risk Management Plans, Vulnerability Management Plans, and Incident Response Plans
• Participate in secure software development lifecycle (SSDLC) activities including design reviews and security validation
• Analyze results of static code analysis, dynamic analysis, and vulnerability scanning tools
• Support SBOM generation and third-party software risk analysis
• Assist in investigation and remediation of security vulnerabilities affecting medical device or cloud infrastructure environments
• Collaborate with DevOps and engineering teams to implement secure configurations, identity management, and network security controls
• Participate in product security incident response activities and post-market cybersecurity monitoring
• Support internal and external security audits related to FDA, ISO 13485, ISO 27001, TIR-57 and healthcare cybersecurity requirements

Requirements:

• Requires a BS degree preferably Cybersecurity, Computer Science, Computer Engineering, a related Engineering discipline and 5+ years' experience in cybersecurity, product security, or cloud security roles
• Strong written and verbal communication skills
• Strong analytical thinking and attention to detail
• Experience working in cross-functional engineering environments
• Familiarity with Threat Modeling, vulnerability scanning and remediation processes
• Experience reviewing technical documentation and regulatory artifacts
• Knowledge of NIST Cybersecurity Framework and NIST 800-series security controls
• Familiarity with OWASP Top 10 and secure software development lifecycle practices
• Experience supporting FDA cybersecurity documentation or 510(k) submissions strongly preferred
• Experience working with regulated medical devices or healthcare software environments