Job Description

Staff Engineer, Medical Device Risk

Aliso Viejo, California, USA

524-New Product Quality

$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)

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