Staff Engineer, R&D

Terumo Neuro; Aliso Viejo (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Terumo Neuro in the United States is seeking a Staff Engineer, R&D to design and develop medical devices. You will create 3-D models in SolidWorks, produce detailed 2-D drawings, write engineering requirements, and support transfer to manufacturing for scale-up.

The role involves cross-functional work with R&D, Operations, Quality, and Regulatory, developing test plans and fixtures, and ensuring robust designs optimized for manufacturability. Strong communication is essential.

Qualifications

• Bachelor’s degree in Engineering or Scientific field.
• Minimum six (6) years of relevant work experience in medical device industry.
• Strong written and verbal communication skills.
• SolidWorks design with detailed 2D drawings and BOMs.
• MS Office proficiency.

Responsibilities

• Support the design and manufacture of medical devices from concept through transfer to Manufacturing.
• Create 3-D designs using SolidWorks and generate detailed 2-D drawings and BOMs.
• Develop test methods, fixtures, and verification/validation plans and reports.
• Collaborate with R&D, Operations, Quality, and Regulatory for design transfers and launch.
• Train Technicians to assemble and test mechanical systems.
• Release revision-controlled designs and documentation in the document control system.
• Assist with post-market sustaining efforts and CAPA-related activities.

Skills

Strong communication

Team collaboration

Problem-solving

Education

Bachelor’s degree in Engineering or Scientific field

Advanced degree preferred

Tools

SolidWorks

MS Office (Word/Excel/Outlook)

Design for manufacturing (DFM)

Job description

13371BR

Job Description:

Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer launch, and post market phases. Work closely with R&D counterparts, Operations, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch and continue supporting product sustainment. Job duties:

• Work in cross-functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs.

• Ability to translate abstract ideas into design solutions using variety of methods including but not limited to simple hand sketches, 3D models, mock-ups, and prototypes.

• Communicate technical concepts effectively to non-technical team members to facilitate cross-functional understanding.

• Develop test plans, protocols, and reports as part of design verification and validation.

• Develop designs that are robust and optimized for manufacturability.

• Evaluate different design solutions and components to determine optimum solution for the application.

• Develop and test prototypes as required during the course of product development.

• Release revision-controlled designs and documentation in document control system.

• Support the design transfer of product from R&D to Manufacturing for volume production.

• Train Technicians to assemble and test mechanical systems.

• Develop and maintain vendor relationships.

• Assist with solving technical challenges encountered during manufacturing.

• Support post market sustaining efforts (e.g., complaint investigations, product training).

• 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 or Scientific field.

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

3. Strong written and verbal communication skills.

4. Working knowledge of fundamental mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics.

5. Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2D drawings and BOMs.

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

Desired Qualifications

1. Advanced degree in Engineering or Scientific field.

2. Experience designing components optimized for injection molding.

3. Experience with developing user centric industrial designs for medical devices.

4. Experience with Finite Element Modeling.

5. Experience designing complex mechanical/electromechanical systems.

6. Experience designing enclosures, chassis, and spatial packaging of components.

7. Working knowledge of medical devices and FDA regulations.

8. Experience with CAPA systems, including complaint handling.

9. Ability to receive the appropriate inoculations required to enter an operating room environment.

Posting Country:

US - United States

Title:

Staff Engineer, 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.