Stay abreast of emerging cybersecurity threats, technologies, and regulations specific to medical devices and health software.
Contribute to OU and enterprise-wide product security strategy and roadmap development.
Drive security integration into all stages of the product lifecycle, from concept and design to postmarket.
Work closely with system architects, software leads, and hardware engineers to embed secure design patterns in both embedded and cloud-connected environments.
Lead or contribute to threat modeling sessions, conduct security risk assessments, and identify mitigation strategies in accordance with IEC 81001-5-1, ISO 14971, and FDA premarket cybersecurity guidance.
Collaborate on the design and implementation of secure architectures, focusing on secure boot, secure communications, data protection, access control, secure software updates, and hardware-software integration.
Support and interpret results from vulnerability scans, penetration tests, and static/dynamic code analysis.
Coordinate with internal teams and third-party vendors to ensure timely and appropriate risk mitigation.
Promote a culture of security awareness within R&D and provide support to more junior engineers.
Ensure alignment with applicable standards (e.g., NIST, IEC 60601-4-5, IEC 81001-5-1) and support security documentation efforts for global regulatory submissions.
Review and assess the cybersecurity posture of third-party suppliers and open-source software components used within product designs.
Support technical investigation and resolution of postmarket security incidents or field issues.
Maintain comprehensive security documentation, including threat model diagrams, risk assessments, shared service inventories, design patterns, security guidelines, and product security plans/reports.
Requirements
Bachelor's degree and 4 years of relevant experience, or a Master’s degree with 2 years of relevant experience
Bachelor’s degree in a relevant engineering field of study (e.g., Computer Engineering, Software Engineering, or related discipline), completed and verified prior to start
Minimum 4 years of relevant experience, or 2 years with an advanced degree
Minimum 1 year of experience integrating security into embedded systems or connected medical devices in a regulated product development environment
Working knowledge of secure development lifecycle (SDLC), secure boot, cryptography, secure firmware update, secure communication, and hardware/software interface security
Master’s degree in a relevant engineering or cybersecurity field