17 days ago
Remote, WorldwideStaff+
Responsibilities
- Lead cybersecurity assurance activities throughout the product life cycle, including risk management plans, threat modeling, vulnerability assessments, security architecture, SBOMs, vulnerability management, security testing, risk reports, and traceability.
- Ensure compliance with applicable regulatory requirements and industry standards and escalate major issues affecting patient safety, cybersecurity, usability, or process adherence.
- Analyze system designs, determine cyber risk profiles, estimate security risks, define controls, and collaborate with hardware and software engineers and Design Assurance, Quality, and Regulatory teams.
- Support cybersecurity regulations, ATO readiness, cyber-signal monitoring and response, continuous process improvement, external audits and submissions, CAPA, supplier audits, and software assurance.
- Supervise, mentor, guide, and coach other cybersecurity assurance engineers.
Requirements
- Bachelor’s degree or higher and at least eight years of cybersecurity and/or cybersecurity risk management experience supporting medical devices.
- Experience with embedded systems, IoT devices, Bluetooth, Wi-Fi, and/or cellular technologies.
- Preferred experience includes ten years of relevant medical-device cybersecurity experience and applying medical-device regulations and standards such as FDA requirements, EU regulations, IEC 81001-5-1, ISO 13485, ISO 14971, and IEC 62304.
- Experience leading threat modeling and vulnerability assessments, applying STRIDE and CVSS, and conducting penetration, fuzz, SAST, and/or DAST testing for embedded or connected systems.
- Experience with SCA, SBOM generation and monitoring, C programming concepts, cryptographic principles, and communicating technical cybersecurity risks and recommendations.
- Experience managing projects and deliverables across cross-functional teams and working with internal stakeholders and external business partners.
Benefits
- Remote position in the United States with up to 5% domestic/international travel.
- Relocation assistance may be authorized.
- Benefits may include medical, dental and vision coverage, health savings accounts, flexible spending accounts, disability and life insurance, voluntary benefits, paid absences, and retirement benefits.