Staff Research Development Engineer

Terumo Neuro; Aliso Viejo (CA); On-site; USD 116,706 - 122,541; Full time

Job summary

Terumo Neuro in California seeks a Staff Engineer, R&D for Electromechanical Devices to support design and manufacturing of medical devices. You will create 3-D designs in SolidWorks, generate detailed 2-D drawings and BOMs, write engineering requirements, develop test methods, and support product launch from design through transfer to manufacturing.

The role involves cross-functional collaboration with Operations, Quality and Regulatory to achieve successful product transfers, robust testing,

Qualifications

• Bachelor's degree in engineering or scientific field is required.
• Minimum six years of relevant experience in the medical device industry.
• Strong written and verbal communication skills.
• Working knowledge of mechanical engineering principles (Fluid Mechanics, Strength of Materials, Statics, Dynamics).
• SolidWorks design expertise with complex designs, clean history, 2D drawings and BOMs.
• Proficient computer skills (MS Word, Excel, Outlook, Teams).

Responsibilities

• Identify customer needs and develop system requirements, specifications, designs, and drawings.
• Translate ideas into design solutions using sketches, 3D models, mock-ups, and prototypes.
• Communicate technical concepts to non-technical team members.
• Develop test plans, protocols, and reports for design verification and validation.
• Design robust, manufacturable components and evaluate alternatives.
• Develop and test prototypes during product development.
• Release revision-controlled designs and documentation.
• Support design transfer from R&D to Manufacturing for volume production.
• Train Technicians to assemble and test mechanical systems.
• Develop and maintain vendor relationships.
• Assist with manufacturing troubleshooting and post-market sustainment.

Skills

Strong communication

Mechanical engineering principles

Education

Bachelor's degree in engineering or sciences

Tools

SolidWorks

MS Word

Excel

Outlook

Teams

Job description

Staff Engineer, R&D (Electromechanical Devices)

Salary Range: $116,706 - $122,541

(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.

What You'll be Doing

• 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 protypes 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).

Required 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.
• Working knowledge of fundamental 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 2D drawings and BOMs.
• Proficient computer skills, including MS Word, Excel, Outlook, and Teams.

What Will Differentiate You from the Crowd

• 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.