Product Security Engineer

Title: Product Security Engineer – Medical Device & SaMD Cybersecurity

About the Role

We're hiring a Product Security Engineer to support security architecture, threat modeling, and risk management for medical devices and Software as a Medical Device (SaMD) platforms. You'll work across engineering, quality, regulatory, and DevOps to build security into the product from design through post-market monitoring.

What You'll Do

• Run product security risk assessments and threat modeling for medical devices and SaMD platforms
• Build cybersecurity documentation for FDA submissions: 510(k) packages, risk management files, SBOM requirements
• Lead security architecture reviews against secure design principles and regulatory expectations
• Own Product Security Risk Management Plans, Vulnerability Management Plans, and Incident Response Plans
• Participate in SSDLC design reviews and security validation
• Review static analysis, dynamic analysis, and vulnerability scan output, and drive remediation
• Support SBOM generation and third-party software risk analysis
• Work with DevOps on secure configs, identity management, and network controls
• Support FDA, ISO 13485, ISO 27001, and TIR-57 audits

What You Bring

• BS in Cybersecurity, Computer Science, Computer Engineering, or related field
• 5+ years in cybersecurity, product security, or cloud security
• Experience with FDA cybersecurity documentation or 510(k) submissions strongly preferred
• Background in regulated medical device or healthcare software environments
• Working knowledge of NIST CSF, NIST 800-series controls, and OWASP Top 10
• Strong written communication for regulatory and technical documentation