Product Security Process Analyst II
About The Position
Terumo Blood and Cell Technologies designs, engineers, and builds medical technology that helps save lives. 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.
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 sufficient to perform the essential functions of the role.
- 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.
- 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.
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.
Benefits
- Multiple group medical, dental and vision plans
- Robust wellness program
- Life insurance and disability coverages
- Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
- 401(k) plan with a matching contribution
- Vacation and sick time programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
