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Staff Engineer, R&D (Medical Devices)

Company:
MicroVention-Terumo
Location:
Aliso Viejo, CA, 92656
Posted:
April 17, 2024
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Description:

Staff Engineer, R&D (Medical Devices)

Working for a company voted Great Places to Work - 2022, the Staff Engineer, R&D (Medical Devices) will 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 and designing test fixtures, supporting product manufacturing and problem solving issues through design, development, design transfer launch and post market phases.

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

Develop and maintain vendor relationships

Assist with solving technical challenges encountered during manufacturing

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

Perform additional duties as assigned

The Skills/Experience Needed for the Staff Mechanical Engineer, R&D (Medical Devices)

Advanced Degree in Mechanical Engineering.

A minimum of six (8) years of medical device experience.

Experience designing and processing laser cut and Nitinol components

Experience with developing user centric industrial designs for medical devices.

Experience with new product design and development, and design verification & validation of neurovascular medical devices.

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.

How You Will Stand Out from the Crowd:

Advanced Degree in Mechanical Engineering / Biomedical Engineering

A minimum of six (8) years of medical device experience, preferably class III devices

Successful track record of bringing a regulatory approved medical device from innovation to market

Experience in metallic (Nitinol, Cobalt Chromium, Stainless Steel, etc.) laser cut stent design and associated processes, highly recommended

Experience in developing complex stent delivery systems

High mechanical aptitude, capable of technically leading junior engineers

MicroVention Perks

15 Days of PTO, 12-13 Paid Holidays, and offices closed last week of December (paid).

Tuition Reimbursement up to $10,000/Year

On-Site/Hybrid/Remote Work Schedules

Focus on Diversity, Equity & Inclusion (DE&I)

Comprehensive Learning & Development Programs

We are an equal opportunity employer (EOE) 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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