Senior Medical Device Risk Engineer

MicroVention, Inc.; Aliso Viejo (CA); On-site; USD 117,000 - 153,000; Full time

Job summary

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.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• 6–8 years in medical device industry in Quality Engineering, Product Development, or Manufacturing with at least 1 year in project management.
• Expertise in global risk regulations: ISO 14971, 21CFR820, EU MDR.
• Translate regulatory requirements into practical procedures.
• Ability to write and review procedures.
• Ability to lead complex technical projects.

Responsibilities

• Evaluate proposed changes to determine risk impact and update risk management docs.
• Review risk impact assessments for safety/efficacy including benefit-risk analyses.
• Lead cross-functional teams in risk management activities and manage risk assessments and control implementation.
• Apply risk management tools like PHA and FMEA to identify critical quality attributes.
• Facilitate cross-functional risk analysis sessions with stakeholders.
• Ensure risk management activities and documentation comply with procedures and regulatory requirements.
• Maintain and improve risk management records aligned with design and lifecycle changes.
• Provide guidance on proper use of risk criteria, tools, and processes.
• Support internal audits and regulatory inspections related to risk management.
• Identify opportunities to improve risk management practices and training.

Skills

Risk assessment

Cross-functional collaboration

Project management

Regulatory compliance

Communication

Analytical thinking

Education

Bachelor’s degree in engineering or related discipline

Tools

MS Excel

MS Word

MS Project

Outlook

Teams

Job description

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.