Senior Medical Device Risk Engineer
microventionAliso Viejo (CA)
Senior Medical Device Risk Engineer
Posted 9 days ago
microventionAliso Viejo (CA)
SENIORITY
Manager
About the role
Terumo Neuro in Aliso Viejo, CA seeks an experienced risk management professional to review risk impact assessments and design changes for product safety and efficacy, ensuring alignment with ISO 14971, 21 CFR 820, and EU MDR.
You will lead cross-functional risk analyses (PHA, FMEA), maintain risk management files, and drive continuous improvement of risk documentation while collaborating with Manufacturing, Quality, Regulatory Affairs, and R&D to support audits and lifecycle activities.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
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Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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