Principal R&D Cybersecurity Architect

Requisition ID:  33439  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

 

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

JOB TITLE: Principal R&D Cybersecurity Architect

 

JOB SUMMARY

Plans and directs major security architecture initiatives across complex medical device projects, applying intensive and diversified knowledge of security engineering principles in broad areas of assignments. Operating within R&D's design control framework, develops and directs security architectures that meet both clinical needs and regulatory requirements while enabling exceptional patient care. Plans, schedules, and coordinates detailed phases of security architecture work across major projects.

 

ESSENTIAL DUTIES

• Serves as organization spokesperson on advanced security projects and programs, providing significant input into corporate security strategy while defining and validating security architectures spanning embedded medical devices and healthcare applications
• Exercises independent judgment in translating regulatory cybersecurity guidance into design inputs and requirements, ensuring compliance with FDA guidance, IEC 81001-5-1, and AAMI TIR57 while evaluating complex intangibles
• Lead security risk management activities as part of product risk management process, integrating with ISO 14971 requirements and anticipating problems across clinical environments, intended use, and benefit-risk analysis
• Develops advanced technological security concepts and guides their development into final products through reusable secure design patterns within R&D's development framework
• Engages actively with, inspires and drives the effectiveness of cross-functional development teams in implementing security controls, ensuring requirements traceability and design history documentation
• Champions and sponsors security innovations within and across products while establishing security design verification and validation protocols aligned with regulatory expectations
• Partners with development teams to integrate security testing into product verification and validation activities, including static analysis, dynamic testing, and clinical use simulation
• Directs post-market surveillance requirements for security monitoring and updates as part of product lifecycle management
• Creates and maintains security-related documentation supporting both development and regulatory submissions
• Leads design reviews focusing on security architecture within the broader product development process
• Mentors R&D teams on integrating security practices into the product development lifecycle, significantly influencing team direction and incorporation of innovative member ideas
• Understands and manages the impact of security-related process changes across multiple areas, identifying risks and implementing innovative solutions for complex problems

MINIMUM QUALIFICATION REQUIREMENTS

 

Education