Product Security Process Analyst II

At Terumo Blood and Cell Technologies, our 8,000+ global associates come to work each day knowing that what we do impacts the lives of patients around the world. We make medical devices and related products used to collect, separate, manufacture, and process various components of blood and cells. With innovative technologies and service offerings, we touch a patient’s life every second of every day.

About the role

The Product Security Process Analyst II plays a key role in strengthening and sustaining product security governance for regulated medical devices. This role concentrates on interpreting regulatory and industry cybersecurity requirements, assessing their applicability, and shaping how those requirements are implemented, documented, and sustained. This position partners closely with Product Security Engineers, R&D, Quality, and Regulatory Affairs to translate evolving cybersecurity regulations and standards into clear, auditable, and practical product security processes.

Responsibilities

• Serve as a product security process subject-matter expert, supporting compliance with FDA cybersecurity guidance and global medical device cybersecurity regulations and standards.
• Support the creation, maintenance, and continuous improvement of product security Policy, SOPs, and work instructions.
• Own or support product security quality plans and CAPA activities, including documentation, tracking, and coordination with cross-functional stakeholders.
• Translate product security requirements into clear, actionable requirements and ensure traceability within the requirements tool.
• Partner with Product Technical Leads, R&D, and Product Security Engineers to ensure product security activities align with quality plans and lifecycle expectations.
• Support internal audits, regulatory agency inspections/audits, and readiness activities related to product security.
• Monitor adherence to defined product security processes and identify gaps or improvement opportunities.
• Act as a connector between Product Security, Quality, and Regulatory teams to ensure consistent execution and communication.
• Occasional travel to other company locations may be required.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Cybersecurity, Biomedical Engineering, or a related technical discipline, or an equivalent combination of education and relevant experience.
• Minimum 5 years of experience in Systems Engineering, Software Development, or Cybersecurity in a regulated environment, preferably medical devices.
• Experience working with regulated products, development processes, or quality systems is strongly preferred.

Skills

• Strong analytical and written communication skills, with the ability to translate complex requirements into clear guidance.
• Ability to work collaboratively across engineering, quality, regulatory, and security teams.
• Comfortable influencing without direct authority and navigating ambiguity.

Physical Requirements

• Typical office environment: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties.

Pay

Target pay range: $123,800.00 to $154,700.00 (salary determined by education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data). Target bonus on base: 7.0%.

Benefits

• Competitive total reward offerings including compensation, benefits, and recognition programs.
• Multiple group medical, dental, and vision plans.
• Robust wellness program.
• Life insurance and disability coverages.
• Voluntary programs such as group accident, hospital indemnity, critical illness, and pet insurance.
• 401(k) plan with matching contribution.
• Vacation and sick time programs.