Senior Medical Device Risk Engineer

Terumo Neuro; Aliso Viejo (CA); On-site; USD 117,000 - 153,000; Full time

Job summary

Terumo Neuro is seeking a Senior Risk Management professional to evaluate risk across R&D, operations, and post-market activities. You will lead cross-functional risk analyses, apply ISO 14971 and related standards, and drive improvements in risk management documentation and processes.

You will coordinate with Manufacturing, Quality, Regulatory Affairs and other teams to ensure risk criteria are properly applied and documented, while guiding continuous improvement of risk management practices

Qualifications

• Bachelor's degree in engineering or other relevant discipline.
• Minimum of 6–8 years of experience in the medical device industry in Quality Engineering, Product Development, or Manufacturing, including at least 1 year in project management.
• Expertise in global regulations for risk assessment, including ISO 14971, 21CFR820, and EU MDR.
• Ability to translate regulatory requirements into practical procedures and to write and review procedures.
• Ability to lead complex technical projects and work effectively in a team.

Responsibilities

• Review risk impact assessments and design changes to determine impact on product risk and update risk management documentation.
• Evaluate risk analyses for product safety and efficacy including benefit-risk analyses.
• Lead cross-functional risk management activities with Manufacturing, Quality, R&D, Regulatory Affairs and others to develop risk assessments and FMEAs.

Skills

Risk Management

Communication

Project leadership

Regulatory understanding

Education

Bachelor's degree in engineering

Tools

MS Excel

Word

Project

Outlook

Teams

Job description

Terumo Neuro is seeking a Senior Risk Management professional to evaluate risk across R&D, operations, and post-market activities. You will lead cross-functional risk analyses, apply ISO 14971 and related standards, and drive improvements in risk management documentation and processes.

You will coordinate with Manufacturing, Quality, Regulatory Affairs and other teams to ensure risk criteria are properly applied and documented, while guiding continuous improvement of risk management practices