- 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
- 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.
- 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
- 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
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Staff Engineer, R&D - Aliso Viejo, United States - MicroVention-Terumo
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
The Skills/Experience Needed for the Staff Mechanical Engineer, R&D (Medical Devices)
How You Will Stand Out from the Crowd:
MicroVention Perks
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.
