Staff Engineer, R&D (Catheter)

Terumo Neuro • Aliso Viejo, CA • 7h ago

13466BR

Title:

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.

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 proto@types

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 pro@types 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

Auto req ID:

13466BR

Location MV:

Aliso Viejo, California, USA

Department Name:

800-California Interventional Systems (CAIS)

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

Some Travel Required (~20%)

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 complex mechanical/electromechanical systems

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.

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.

External-Facing Title:

Staff Engineer, R&D (Catheter)

Posting Country:

US - United States

Salary Range:

$116,706.01-$145,882.52 (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)

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.

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