Staff Engineer, Medical Device Risk

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

Job summary

Terumo Neuro in California seeks a risk management specialist to review risk assessments and design change notifications, ensuring product safety and efficacy.

You will lead cross-functional risk analyses with Manufacturing, Quality, R&D, Regulatory Affairs, and other stakeholders, applying PHA, FMEA, and risk criteria.

This role supports compliance with quality systems and regulatory requirements, driving continuous improvement of risk management documentation.

Qualifications

• Experience with risk management in medical devices and quality systems.
• Proficient in risk assessment methods such as PHA and FMEA.
• Ability to lead cross-functional risk analyses with R&D, Operations, and Regulatory.
• Knowledge of regulatory requirements and documentation practices.

Responsibilities

• Review risk assessments and design change notifications for safety and efficacy impact.
• Lead cross-functional risk analysis sessions with Manufacturing, Quality, R&D, and Regulatory.
• Maintain risk management files and ensure compliance with procedures.
• Support internal audits and regulatory inspections related to risk management.
• Identify opportunities to improve risk management processes and tools.

Skills

Risk management

PHA

FMEA

Cross-functional leadership

Regulatory knowledge

Job description

Responsible for reviewing risk impact assessments and design change notifications received from R&D and Operations to evaluate potential impact to product safety, effectiveness, and the applicable risk management file. Apply risk management principles across R&D, Operations, and Post-Market Surveillance. Promote existing tools and proper utilization of the risk acceptability criteria. Facilitate cross-functional collaboration sessions with stakeholders from Manufacturing, Quality, R&D, Regulatory Affairs, and other applicable functions to perform and document risk analyses, including PHA, FMEA, and risk impact assessments.

• Evaluate proposed design, process, supplier, and manufacturing changes to determine the impact on product risk and recommend updates to risk management documentation.
• Review risk impact assessments to determine potential impact to product safety and efficacy including benefit risk analysis.
• Serve as the technical lead for cross-functional teams in the development, maintenance, and execution of risk management files, including risk assessments, hazard analyses, and FMEAs. Apply established risk management procedures and quality system requirements to risk analysis, risk evaluation, risk control implementation, residual risk assessments, and benefit-risk determinations.
• Use risk management tools and methodologies, including Preliminary Hazard Analysis (PHA), Failure Modes, and Effects Analysis (FMEA) to identify essential requirements and attributes critical to quality.
• Facilitate cross-functional risk analysis sessions with Manufacturing, Quality, R&D, Regulatory Affairs, and other applicable stakeholders.
• Ensure risk management activities, decisions, and supporting documentation are complete, accurate, and compliant with applicable procedures and regulatory requirements.
• Drive maintenance and continuous improvement of risk management records, ensuring alignment with design changes, manufacturing changes, post-market data, and product lifecycle activities.
• Provide technical guidance to cross-functional partners on proper use of risk criteria, risk tools, and risk management processes.
• Support internal audits, regulatory inspections, and quality system activities related to medical device risk management.
• Identify and recommend opportunities to improve risk management practices, templates, tools, and training to promote consistent application across the organization.
• Comply with applicable laws, regulations, standards, and Quality Management System requirements, while demonstrating ethics and integrity in all matters.
• Perform additional duties as assigned.

Job ID 14433BR

Salary Range:

$116,706 - $153,176 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)