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Aliso Viejo

    Staff Engineer, R&D - Aliso Viejo, United States - MicroVention-Terumo

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    Upper Management / Consulting
    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
    • Conduct and support product evaluations through research, design, Development, evaluation, and validation of new test models and methods
    • 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)

    1. Advanced Degree in Mechanical Engineering.
    2. Minimum Six (6) years of relevant work experience in medical device industry.
    3. Strong written and verbal communication skills.
    4. Strong understanding and experience with computational & experimental anatomical vascular modeling through application of 3D image processing and rapid prototyping
    5. Working knowledge of fundamental mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics, and Dynamics.
    6. Working knowledge of vascular anatomy and physiology
    7. Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2D drawings and BOMs.
    8. Proficient computer skills, including MS Word, Excel, Outlook, and Teams.

    How You Will Stand Out from the Crowd:

    1. Advanced degree in Engineering or Scientific field.
    2. Experience designing components optimized for injection molding.
    3. Knowledge of vascular anatomy and physiology with extensive focus on neurovascular disease
    4. Endovascular device experience
    5. Experience with Finite Element Modeling, Computational Fluid Dynamics
    6. Experience designing complex mechanical/electromechanical systems.
    7. Working knowledge of medical devices and FDA regulations.
    8. Experience with CAPA systems, including complaint handling.
    9. Ability to receive the appropriate inoculations required to enter an operating room environment.

    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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