Staff Engineer, Medical Device Risk

Terumo Neuro; Aliso Viejo (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Terumo Neuro in California is seeking a Staff Engineer, Medical Device Risk to review risk assessments, lead risk analyses, and coordinate cross-functional risk management activities. You will apply risk management principles across R&D, Operations, and Post-Market Surveillance, ensuring compliance with procedures and regulatory requirements.

The role requires 6–8 years of experience in the medical device industry, expertise in ISO 14971, 21 CFR 820, EU MDR, and strong communication skills for

Qualifications

• 6–8 years of experience in medical device industry (Quality Engineering, Product Development, or Manufacturing).
• Experience with ISO 14971, 21 CFR 820, and EU MDR risk management guidelines.
• Ability to translate regulation requirements into practical procedures.
• Ability to lead complex technical projects and write procedures.

Responsibilities

• Evaluate proposed design, process, supplier, and manufacturing changes to assess risk impact and update risk management docs.
• Review risk impact assessments for safety and efficacy implications and benefit-risk analysis.
• Serve as technical lead for cross-functional risk management files, including risk assessments, hazard analyses, and FMEAs.
• Use PHA, FMEA to identify essential requirements and critical quality attributes.
• Facilitate cross-functional risk analysis sessions with Manufacturing, Quality, R&D, Regulatory Affairs, and others.
• Ensure risk management activities and decisions are compliant with procedures and regulatory requirements.
• Drive maintenance and improvement of risk management records aligned with changes and lifecycle activities.
• Provide guidance on proper use of risk criteria and tools to cross-functional partners.
• Support internal audits and regulatory inspections related to medical device risk management.

Skills

Risk assessment

Project leadership

Written & verbal communication

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

Excel

Word

Project

Outlook

Teams

Job description

14433BR

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. 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.
• Perform additional duties as assigned.

Qualifications:

1. Bachelor's degree in engineering or other relevant discipline.
2. 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.
3. 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.
4. Proficient at transferring medical device regulatory requirements into practice. Ability to translate regulation requirements into practical procedures.
5. Ability to write and review procedures.
6. Ability to lead complex technical projects.
7. Ability to work effectively and confidently in a team environment.
8. Excellent written and verbal communication skills.
9. Proficient with MS Excel, Word, Project, Outlook, and Teams.

Desired Qualifications

1. Demonstrated emotional intelligence with the ability to effectively facilitate meetings, foster collaboration, and build strong working relationships.
2. Detail-oriented team player with a positive attitude, strong work ethics, and a willingness to learn and grow through feedback.
3. 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.

Fair Chance Ordinance

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.

Posting Country:

US - United States

Title:

Staff Engineer, Medical Device Risk

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