Clinical Engineering Manager, R&D

Terumo Neuro; Aliso Viejo (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Terumo Neuro is seeking a Clinical Engineering Manager in R&D to lead a team of engineers from entry to senior level on diverse projects. You will drive development and launch efforts, research new ideas, and manage design history while ensuring adherence to quality systems and regulatory requirements.

The role requires strong communication, multi-project management, and hands-on use of design and management tools.

Qualifications

• Bachelor's degree in engineering or related field.
• Minimum six (6) years of relevant work experience in medical device industry.
• Minimum one (1) year of management experience.
• Knowledge of and ability to use design/engineering and management software and equipment.
• Strong written and verbal communication skills.
• Proficient computer skills including MS Word, Excel, Project, Outlook, Teams, and SolidWorks.

Responsibilities

• Lead a group of individuals from entry level to junior level on defined projects.
• Direct subordinates toward company objectives in an efficient and effective manner.
• Collaborate cross-functionally with R&D, Operations, Quality, and Regulatory Affairs to achieve objectives.
• Manage multiple large-scale projects and timelines without guidance.
• Independently manage projects and timelines using established project management methodology.
• Communicate project status and issues clearly to the organization.
• Prepare design modifications and develop designs with appropriate departments.

Skills

Cross-functional collaboration

Strong communication

Project management

MS Office proficiency

Education

Bachelor's degree in engineering

Advanced engineering degree

Tools

MS Word

Excel

Project

Outlook

Teams

SolidWorks

Job description

14132BR

Job Description:

Manage individuals from entry-level to junior-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties:

• Manage a group of individuals of varying technical experience from entry level to junior level on projects of defined scope and diversity.

• Direct subordinates toward clear company objectives in an efficient and effective manner.

• Collaborate cross functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues.

• Manage multiple large-scale project(s) and/or multiple smaller scale projects and timelines without guidance.

• Independently manage project and timelines using established project management methodology.

• Communicate project status and issues in a timely, clear, and appropriate manner to the organization.

• Analyze and/or direct the analysis of research data and proposed product specifications to determine feasibility of product proposals.

• 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.

• Plan and/or prepare quality system documentation, specifications, and detailed drawings.

• 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.

Qualifications:

1. Bachelor’s degree in engineering related field including, but not limited to, Mechanical, Bioengineering, Electrical, Physics, Chemistry, Engineering, or any other related field.

2. Minimum six (6) years of relevant work experience in medical device industry.

3. Minimum one (1) year of management experience.

4. Knowledge of and ability to use design/engineering and management software and equipment to perform engineering and management tasks.

5. Strong written and verbal communication skills.

6. Proficient computer skills including MS Word, Excel, Project, Outlook, Teams, and SolidWorks.

Desired Qualifications

1. Advanced degree in Engineering related field including, but not limited to, Mechanical, Bioengineering, Electrical, Physics, Chemistry, Engineering, or any other related field.

2. Minimum ten (10) years of relevant work experience in medical device industry.

3. Minimum two (2) years of management experience.

4. In depth knowledge of neurovascular and peripheral vascular anatomy and its clinical application.

5. Proficiency with angiosuite imaging technologies, including acquisition and interpretation.

6. Understanding of vascular modeling and simulated use.

7. Knowledge of finite element analysis (FEA) and computational fluid dynamics (CFD)

8. Experience with designing products for endovascular procedures and required testing for regulatory submissions.

Physical

• Extended periods of computer use.

• Extended periods of sitting or standing.

• 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).

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.

Title:

Clinical Engineering Manager, R&D

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.