We are seeking a Cybersecurity Engineer for a Secure Connectivity Board (SCB) PCB project with strong experience in securing medical devices and navigating regulatory requirements, including FDA submissions (510(k)).

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This role will focus on integrating cybersecurity throughout the SCB product lifecycle, ensuring compliance with global regulations, and implementing industry-standard tools and practices.

Key Responsibilities

• Design, implement, and maintain cybersecurity controls for the SCB device across the full product lifecycle (design, development, deployment, and post-market).
• Support cybersecurity activities related to FDA submissions, including 510(k) premarket notifications and cybersecurity documentation for medical devices.
• Ensure compliance with regulatory standards such as FDA guidance, ISO 14971, IEC 62304, and IEC 81001-5-1.
• Conduct threat modelling, risk assessments, and vulnerability analysis for connected medical devices.
• Prepare Penetration tests with dedicated expert team.
• Develop and maintain cybersecurity risk management files and documentation for regulatory audits.
• Integrate secure software development lifecycle (Secure SDLC) practices into engineering workflows.
• Perform static and dynamic application security testing (SAST/DAST).
• Collaborate with cross-functional teams (R&D, Quality, Regulatory Affairs) to ensure security-by-design principles.
• Monitor and respond to vulnerabilities, including post-market surveillance and coordinated vulnerability disclosure.
• Support incident response and remediation planning for cybersecurity events.

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Technical Skills

Experience with cybersecurity tools and technologies such as:

Application Security & Code Analysis

• Black Duck (software composition analysis)
• Fortify (SAST)
• Checkmarx
• Veracode
• SonarQube

Vulnerability Management & Testing

• Nessus
• OpenVAS
• Burp Suite
• OWASP ZAP
• Metasploit

Endpoint & Network Security

• CrowdStrike / Carbon Black
• Wireshark
• Snort / Suricata

Cloud & Infrastructure Security

• AWS Security Hub / Azure Security Center
• Terraform security tools (e.g., Checkov)

DevSecOps & Automation

• Jenkins, GitLab CI/CD security integrations
• Docker/Kubernetes security (e.g., Aqua, Twistlock/Prisma Cloud)

Regulatory & Standards Knowledge

• FDA Premarket and Postmarket Cybersecurity Guidance
• FDA 510(k) submission process
• ISO 14971 (Risk Management)
• IEC 62304 (Medical Device Software Lifecycle)
• IEC 81001-5-1 (Health Software Security)
• HIPAA (as applicable)

Preferred Qualifications

• Certifications such as CISSP, CEH, or CSSLP
• Experience with penetration testing of embedded or IoT devices
• Knowledge of SBOM (Software Bill of Materials) requirements
• Experience working with third-party vendors and security assessments

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