Product Security Process Analyst II

Requisition ID:  35373  

At Terumo Blood and Cell Technologies, our 8,000+ 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.

Product Security Process Analyst II

JOB SUMMARY

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.

ESSENTIAL DUTIES

• 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.

OTHER DUTIES AND RESPONSIBILITIES

• May be required to travel to other company locations on occasion.

MINIMUM QUALIFICATION REQUIREMENTS

Education

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.

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 requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:  $123,800.00 to $154,700.00  -  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:  7.0%

We anticipate this requisition will be open for a minimum of five days, from    . We encourage your prompt application.

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.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
• We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

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.