Staff Engineer, Med Device Risk (Quality)

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

$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)

What You'll Be Doing

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.

Job duties:

• 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.

Qualifications

• Bachelor’s degree in engineering or other relevant discipline.
• Minimum of six (6) to eight (8) years of experience in medical device industry operating in Quality Engineering, Product Development, or Manufacturing, including a minimum of one (1) year of experience in project management.
• Expertise in global regulations pertaining to risk assessment. Experience in the application of applicable risk management regulations and guidance documents, including ISO 14971, 21CFR820, and EU MDR.
• Proficient at transferring medical device regulatory requirements into practice. Ability to translate regulation requirements into practical procedures.
• Ability to write and review procedures.
• Ability to lead complex technical projects.
• Ability to work effectively and confidently in a team environment.
• Excellent written and verbal communication skills.
• Proficient with MS Excel, Word, Project, Outlook, and Teams.

Desired Qualifications

• Demonstrated emotional intelligence with the ability to effectively facilitate meetings, foster collaboration, and build strong working relationships.
• Detail-oriented team player with a positive attitude, strong work ethics, and a willingness to learn and grow through feedback.
• Knowledge of emerging AI technologies and desire to adopt applicable technologies to streamline and create efficiencies.

Physical

• Extended periods of computer use.
• Extended periods of sitting, standing, or speaking.
• Light lifting, up to 25 lbs.
• May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
• Domestic and international travel as required, approximately 10%-15%

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.