Silk Road Medical

1213 Innsbruck Dr.
Sunnyvale , CA

R&D Engineer

Silk Road Medical
Sunnyvale, CA Full-time
Posted on June 7, 2019

Summary:

The R&D Engineer will use mechanical engineering experience and knowledge to design, develop and evaluate minimally invasive medical devices intended to treat conditions in the vascular space. This role will also support field training and education activities for end users and the company’s field-based personnel.

Key Responsibilities:

  • Field Training Support shall include:
    • Develop/Refine system for field training support with Sunnyvale Logistics team:
      • Management if equipment and supplies inventory
      • Coordination with Office of Medical Affairs to ensure field training workshops are adequately supported
    • Onsite support for field training workshops
      • Lab set-up
      • Equipment troubleshooting; onsite repair as needed
      • Direct interaction with field personnel and customers
    • Training Model Design & Development
      • Work with a cross-functional team (including R&D, Clinical, Medical Education & physician customers) to conceptualize & develop new models to further enhance training and education activities.
      • Responsible for design, fabrication and maintenance of new educational models.
  • New Product Development & Sustaining Engineering Activities shall include:
    • Work with a cross-functional team to develop new products to augment and enhance the company’s existing product offerings.
    • Develop test methods and associated fixtures to be used in the testing and evaluation of new products.
    • Support design verification & validation activities to ensure that product designs meet the customer needs. This shall include bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate
    • Provide engineering support for the investigation and resolution of product complaints

Skills, Knowledge and Qualifications:

  • BS in Biomedical Engineering, Mechanical Engineering or a related discipline
  • MS in Biomedical Engineering, Mechanical Engineering or a related discipline a plus
  • 2-3 years R&D experience in the Medical Device Industry. Previous hands-on bench skills & prototyping experience.
  • Computer Skills: Computer 3D Modeling (SolidWorks), FEA desirable (not required), Microsoft Office Suite
  • Understanding of FDA Regulations and Quality Systems requirements for Medical Device Manufacturers
  • Excellent oral and written communication skills.
  • Ability to work well within a cross-functional team environment.
  • Highly organized, energetic, self-starter
  • Flexible with respect to work assignments, which will include (but not limited by): Engineering Design, Hands-on Prototyping, Bench Testing, Documentation, and Field Training, and direct customer interaction.

Travel

  • 25% domestic travel