Research and Development Staff Engineer

Terumo Neuro; Aliso Viejo (CA); On-site; USD 116,706 - 138,541; Full time

Job summary

A medical device company is seeking an experienced engineer to support the design and manufacture of medical devices. This role involves creating 3-D designs, developing test methods, and collaborating with cross-functional teams. Candidates must have a bachelor's degree in engineering, six years of experience in the medical device industry, and strong SolidWorks skills. Additional qualifications include familiarity with FDA regulations and advanced design techniques for injection molding. Competitive compensation is offered.

Qualifications

• Minimum six years of relevant work experience in the medical device industry.
• Previous experience in design control deliverables and/or Quality Design.
• Strong design expertise using SolidWorks and creating complex designs.

Responsibilities

• Identify customer needs and develop system requirements.
• Translate abstract ideas into design solutions.
• Develop test plans, protocols, and reports for design verification.

Skills

SolidWorks design expertise

Communication skills

Electro-mechanical engineering principles

MS Office proficiency

Education

Bachelor’s degree in Engineering or Scientific field

Job description

$116,706 - $138,541 (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)

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

1. Work in cross‑functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs.
2. Translate abstract ideas into design solutions using a variety of methods including simple hand sketches, 3‑D models, mock‑ups, and prototypes.
3. Communicate technical concepts effectively to non‑technical team members to facilitate cross‑functional understanding.
4. Develop test plans, protocols, and reports as part of design verification and validation.
5. Develop designs that are robust and optimized for manufacturability.
6. Evaluate different design solutions and components to determine optimum solution for the application.
7. Develop and test prototypes as required during the course of product development.
8. Release revision‑controlled designs and documentation in document control system.
9. Support the design transfer of product from R&D to Manufacturing for volume production.
10. Train technicians to assemble and test mechanical systems.
11. Develop and maintain vendor relationships.
12. Assist with solving technical challenges encountered during manufacturing.
13. Support post‑market sustaining efforts (e.g., complaint investigations, product training).
14. Comply with applicable laws and regulations, adhere to Quality Management System processes and requirements, and demonstrate ethics and integrity in all matters and at all levels throughout the organization.

Required Qualification

• Bachelor’s degree in Engineering or Scientific field.
• Minimum six (6) years of relevant work experience in the medical device industry.
• Previous experience in design control deliverables and/or Quality Design to support commercial products (sustaining R&D).
• Strong written and verbal communication skills.
• Working knowledge of fundamental electro‑mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics.
• Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2‑D drawings and BOM.
• Proficient computer skills, including MS Word, Excel, Outlook, and Teams.

Desired Qualifications

• Advanced degree in Engineering or Scientific field.
• Experience designing components optimized for injection molding.
• Experience with developing user‑centric industrial designs for medical devices.
• Experience with Finite Element Modeling.
• Experience designing enclosures, chassis, and spatial packaging of components.
• Working knowledge of medical devices and FDA regulations.
• Experience with CAPA systems, including complaint handling.
• Ability to receive the appropriate inoculations required to enter an operating room environment.

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.

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.