Jobs

Description

Remote  but would prefer on site .

The Product Security Engineer will support the security architecture, design review, and risk management activities for medical devices and Software as a Medical Device (SaMD) platforms. This role focuses on ensuring the security, privacy, and regulatory compliance of medical devices.

• The candidate will work cross-functionally with engineering, quality, regulatory, and DevOps teams to implement secure design practices.
•  Large portion of this job requires performing threat modeling, and support cybersecurity risk management activities aligned with FDA guidance.
• This position contributes to security documentation supporting 510(k) submissions, post-market cybersecurity management, and secure development lifecycle (SDL) activities.

Essential Job Functions:

• 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.

Job 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.
• Experience supporting FDA cybersecurity documentation or 510(k) submissions strongly preferred.
• Experience working with regulated medical devices or healthcare software environments
• 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.