Principal R&D Cybersecurity Architect

Company: TERUMO BCT, INC
Location: Lakewood
Posted on: April 1, 2025

Job Description:

Principal R&D Cybersecurity ArchitectDate: Mar 3, 2025Location: Lakewood, USRequisition ID: 33439At Terumo Blood and Cell Technologies, our 7,000+ global associates are 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 ArchitectJOB SUMMARYPlans 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 the 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 REQUIREMENTSEducationMaster's degree in Computer Science, Software Engineering, Electrical Engineering, or equivalent combination of education and experience demonstrating expertise in medical device security.Experience
• Minimum 15 years software development experience, with at least 10 years in security architecture and implementation in regulated environments, including medical device software security or comparable regulated industries such as healthcare technology.
• Experience integrating security practices into design controls and product risk management.
• Demonstrated experience developing medical device software under quality systems.
• Track record of successful regulatory submissions incorporating cybersecurity documentation.Skills
• Expert knowledge of medical device security architecture and secure development practices within regulated environments, with demonstrated success leading product development initiatives.
• Deep understanding of cryptographic implementations suitable for medical devices and clinical environments, including development of advanced technological solutions.
• Strong experience with secure communications protocols appropriate for medical device ecosystems, serving as primary technical contact on significant projects.
• Proven ability to perform security risk management within the broader product risk management framework while exercising independent judgment.
• Expertise in security testing methodologies aligned with medical device verification and validation requirements.
• Comprehensive knowledge of medical device security standards and regulations, with ability to influence organizational strategy.
• Experience implementing secure development practices with demonstrated technical innovation.
• Strong technical writing abilities for regulatory submissions and design history documentation.
• Exceptional problem-solving skills balancing security requirements with clinical safety and usability.
• Strong collaboration skills working within and leading multidisciplinary product development teams.
• Proven mentorship experience in regulated product development with ability to drive team effectiveness.
• Demonstrated ability to communicate complex technical information effectively to senior stakeholders and cross-functional teams.-Or-An equivalent competency level acquired through a variation of these qualifications may be considered.PHYSICAL REQUIREMENTSTypical Office Environment requirements include: reading, speaking, hearing, close vision, traverse, bending, sitting, and occasional lifting up to 20 pounds.Additional Physical RequirementsHybrid Position requiring 3 days per week in person at the Lakewood, CO Headquarters, and additional days required to perform the role.Target Pay Range: $145,400.00 to $181,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Target Bonus on Base: 20.0%At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life, and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental, and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance, and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security, and overall peace of mind.We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.Terumo Blood and Cell Technologies is committed to providing a safe, healthy, and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
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Keywords: TERUMO BCT, INC, Lakewood , Principal R&D Cybersecurity Architect, Professions , Lakewood, Colorado