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Southern California

  • Senior or Principal R&D Engineer – stent/implant design – 2 spots open!

    Lake Forest, CA

    Primary responsibilities include:

    • Design/improve stents and delivery system components and accessories.
    • Apply Mechanical Engineering knowledge to the design and development of new products.
    • Solve Mechanical Engineering problems at the component, subassembly, and system level.
    • Support manufacturing process development.
    • Implement design for manufacturability (DFM) improvements.
    • Develop test methods for both feasibility/research & for Design Verification.
    • Conduct testing on devices (both feasibility & Design Verification).
    • Identify root cause and develop solutions to issues identified during testing.
    • Create, update, and release quality system documents.
    • Present/communicate findings to influence team/design/management.
    • Work with vendors to improve vendor-supplied components and address issues as they arise.
    • Design fixtures for both manufacturing and device/component testing.
    • Support commercialization activities and manufacturing site transfers.
    • Conduct all work in compliance with internal and external policies and procedures, QSR and FDA regulations and ISO standards.

    Required Qualifications:

    • Bachelor’s degree in Engineering is required, 5 years experience minimum
      • Exposure to design of experiments
      • Design control systems
      • Specification development
      • Prototyping
    • Experience in the medical device industry with emphasis on minimally invasive procedures

    Preferred Qualifications:

    • Proven Track record of early technical development and early-stage R&D all the way to commercialization.
    • Ability to interact with cross functional partners and the ability to escalate issues.
    • Advanced degree in Engineering is preferred.
    • Knowledge and experience with implant and delivery system product development from design to product launch, catheters a plus.
    • Will need to be a highly motivated self-starter who is able to achieve results with minimal direction.
    • Knowledge of device Design Control, Quality Systems, documentation.
    • Good communication skills, written and verbal.
    • Experience working in cross functional teams and independent contributor role.
    • Experience developing test plans.
    • Experience with CAD and/or solid modeling in programs such as Solidworks.
    • Experience with extrusions, materials, braided shafts, articulating designs, varied French sizes, etc.

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