Sr . R&D Engineer

Silk Road Medical

Sunnyvale, CA, US
  • Job Type: Full-Time
  • Function: Engineering Hardware
  • Post Date: 04/27/2021
  • Website: silkroadmed.com
  • Company Address: 735 N. Pastoria Ave., Sunnyvale, CA, 94085

About Silk Road Medical

Silk Road Medical Inc is a medical device company focused on reducing the risk of stroke and its devastating impact. Its approach for the treatment of carotid artery disease is called as transcarotid artery revascularization, or TCAR. The TCAR relies on two concepts - minimally-invasive direct carotid access in the neck and high-rate blood flow reversal during the procedure to protect the brain.

Job Description

The Sr. R&D Engineer is responsible for the design and development of new and improved products and procedures to address vascular diseases and conditions using minimally invasive techniques.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Design, prototype and develop novel design solutions for catheter-based products to improve performance and ease of use in clinical procedures. 
  • Work collaboratively with Marketing, Clinical, Medical Director, and physician advisors to understand customer requirements. Develop deep understanding of procedural constrains, needs, and customer expertise to better inform this understanding.
  • Establish and maintain partnerships with OEM suppliers, development partners, and other vendors as projects require.
  • Maintain Design Control activities for new product development from initial concept through commercialization. These activities may include the following:  developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies.
  • Develop and lead verification and 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 
  • Perform troubleshooting of issues related to new products as related to design, material, or process. 
  • Work collaboratively with other company functions as needed, including R&D, Marketing, Operations, Quality, Clinical and Regulatory to ensure project success.
  • Support the development and upkeep of the Company’s Quality System in conjunction with the Company’s Quality Department
  • Work with Marketing and Medical Affairs to develop training tools and models; direct interface with field personnel and customers.

 

 REQUIREMENTS / QUALIFICATIONS:

  • BS in Biomedical Engineering, Mechanical Engineering, or a related discipline
  • MS in Biomedical Engineering, Mechanical Engineering, or a related discipline a plus. 
  • Minimum of 6 years of experience in industry, 4 of which are in medical device R&D. 
    1. Previous experience with catheter design and manufacturing (i.e. coil winding, braiders, shaft design, handle design) is a plus.  
    2. Previous experience with implantable nitinol devices is a plus.
  • Extensive Product Development Process (PDP) experience for Medical Devices.   Specifically, Design Control, Design Verification & Validation, Test Method Validation.
  • Excellent hands-on design and prototyping skills.  
  • Highly organized, energetic, self-starter who exhibits strong communication skills with cross-functional team members, project leads, and physician advisors. 
  • Technical Leadership experience and strong report writing, drafting and documentation skills.  
  • Proficient with the following:  3D Modeling (SolidWorks), FEA desirable (not required), Microsoft Office Suite. 
  • Strong understanding of FDA Regulation and Quality systems requirements for Medical Device Manufacturers 
  • Be willing to travel up to 20%

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.