Principal R&D Engineer

Terumo Neuro; California (MO); On-site; USD 129,000 - 170,000; Full time

Job summary

Terumo Neuro is seeking a Principal R&D Engineer to lead and support development of medical device products in Aliso Viejo, CA. You will write or verify specifications, sustain processes, and design fixtures, ensuring prototypes meet requirements.

You will mentor teams, direct test methods and data analysis, and contribute to regulatory submissions while maintaining high standards of quality and ethics.

Qualifications

• Bachelor's degree in mechanical engineering, Industrial Engineering, or Materials Science Engineering.
• Minimum of ten (10) years of relevant work experience in medical device industry.
• Strong written and verbal communication skills.
• Ability to design and develop medical devices.
• Ability to read and prepare technical documentation.
• Possess working knowledge of medical device manufacturing equipment/processes.
• Knowledge of medical and technical development.
• Expert proficiency with MS Word, Excel, PowerPoint, Minitab, SolidWorks and/or other CAD systems.

Responsibilities

• Develop new product concepts and products by applying various engineering disciplines, such as mechanical, electrical, materials, bioengineering, or other relevant fields.
• Provide engineering design and process development, and/or sustain engineering support.
• Develop products or processes, or the capabilities to support them, such as test methods, equipment/fixtures, data engineering, statistics, software coding and application, engineering/business intelligence, or various analytical methods, etc.
• Generate intellectual property; write invention disclosures.
• Specify and/or direct the specification and testing of new materials and designs.
• Confer with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems, and develop designs.
• Support projects through regulatory submissions and approvals.
• Largely self-directed and capable of meeting project goals with minimal supervision.
• Lead projects and mentor Assemblers, Technicians, and others as needed.
• Lead all activities relating to test method development, data analysis, root cause investigations, and formal test report release.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Job description

Title:

Principal R&D Engineer

Job Description:

Support and lead the development of medical device products, including writing or verifying specifications; maintaining product process; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts and/or prototypes meet their requirements. Job duties:

• Develop new product concepts and products by applying various engineering disciplines, such as mechanical, electrical, materials, bioengineering, or other relevant fields2. Provide engineering design and process development, and/or sustain engineering support.
• Develop products or processes, or the capabilities to support them, such as test methods, equipment/fixtures, data engineering, statistics, software coding and application, engineering/business intelligence, or various analytical methods, etc.
• Generate intellectual property; write invention disclosures.
• Specify and/or direct the specification and testing of new materials and designs.
• Confer with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems, and develop designs.
• Support projects through regulatory submissions and approvals.
• Largely self-directed and capable of meeting project goals with minimal supervision.
• Lead projects and mentor Assemblers, Technicians, and others as needed.
• Lead all activities relating to test method development, data analysis, root cause investigations, and formal test report release.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Auto req ID:

13566BR

Location MV:

Aliso Viejo, California, USA

Department Name:

800-California Interventional Systems (CAIS)

Qualifications:

1. 1. Bachelor's degree in mechanical engineering, Industrial Engineering, or Materials Science Engineering.
2. 2. Minimum of ten (10) years of relevant work experience in medical device industry.
3. 3. Strong written and verbal communication skills.
4. 4. Ability to design and develop medical devices.
5. 5. Ability to read and prepare technical documentation.
6. 6. Possess working knowledge of medical device manufacturing equipment/processes.
7. 7. Knowledge of medical and technical development.
8. 8. Expert proficiency with MS Word, Excel, PowerPoint, Minitab, SolidWorks and/or other CAD systems.

Desired Qualifications

1. 1. Advanced degree in Mechanical Engineering, Industrial Engineering, or Materials Science Engineering.
2. 2. Ability to effectively manage internal and external customer relationships as well as leading different key players on achieving a goal.
3. 3. Ability to work closely and effectively with multiple departments and associates.
4. 4. Ability to prioritize and meet deadlines in a timely manner.

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.

Salary Range:

$129,000 - $169,500 (Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

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.