Lead Product Security Engineer
5 days ago
*this is a hybrid-onsite role 3X per week in San Diego, CA
Join a mission-driven team building secure, innovative medical diagnostic technologies that improve lives every day. Our Diagnostics Software Engineering (R&D) team is seeking a
Lead Product Security Engineer
with strong medical device or instrument security experience to serve as the cybersecurity SME for our Cytology R&D group.
In this role, you'll drive secure-by-design principles, ensure compliance with FDA cybersecurity expectations, and embed robust security practices across the full product lifecycle—including post-market.
What You'll Do
- Monitor emerging threats and assess security risks across complex software, instrumentation, and connected systems.
- Enhance secure-by-design practices and support secure architecture, documentation, and design controls.
- Define security requirements and controls informed by use cases, threat models, and CVE analysis.
- Lead risk assessments and Security Risk Management activities for vulnerabilities and design issues.
- Support automated vulnerability scanning, SBOM accuracy, and continuous monitoring processes.
- Collaborate closely with Product Engineering, DevSecOps, Regulatory, and Quality teams.
- Guide secure update/patch management architecture and support incident response and root cause analysis.
- Review code analysis results and third-party software evaluation reports.
Required experience:
- Bachelor's/Master's in Computer Science, Cybersecurity, or related field.
- 8–12+ years in product security or cybersecurity engineering.
- Industry certifications (CISSP, Security+, etc.).
- Strong communication and cross-functional collaboration skills.
- Experience in FDA-regulated environments and deep familiarity with regulatory cybersecurity standards.
- Proficiency with Windows OS, cloud environments, scripting (Python, PowerShell), and security frameworks/tools.
Preferred experience:
- Supporting regulatory audits and FDA submissions with security documentation.
- Working knowledge of FDA cybersecurity guidance and standards including ISO, IEC, NIST, AAMI, UL, HIPAA, GDPR, and others.
- Translating cybersecurity requirements into product requirements and verification plans.
- Penetration testing, continuous security testing frameworks, or automated test suites.
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