Note: The job is a remote job and is open to candidates in USA. The employer is a medical device manufacturer developing medical devices and Software as a Medical Device (SaMD) platforms. The Product Security Engineer will lead threat modeling, cybersecurity risk management, security architecture reviews, and regulatory documentation supporting FDA submissions.
Responsibilities
- Run product security risk assessments and threat modeling for medical devices and SaMD platforms
- Build cybersecurity documentation for FDA submissions: 510(k) files, risk management files, SBOM requirements
- Review security architecture against secure design principles and regulatory expectations
- Write and maintain Risk Management Plans, Vulnerability Management Plans, and Incident Response Plans
- Analyze output from static/dynamic analysis and vulnerability scanning tools
- Support SBOM generation and third-party software risk analysis
- Work with DevOps and engineering on secure configs, identity management, and network controls
- Support audits tied to FDA, ISO 13485, ISO 27001, and AAMI TIR57
Skills
- BS in Cybersecurity, Computer Science, Computer Engineering, or a related engineering field
- 5+ years in cybersecurity, product security, or cloud security
- Background with regulated medical devices or healthcare software
- Working knowledge of NIST CSF and NIST 800-series controls
- Familiarity with OWASP Top 10 and secure SDLC practices
- Experience with FDA cybersecurity documentation or 510(k) submissions is strongly preferred
Benefits
- Remote work in San Diego, CA
Company Overview
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