Sr. R&D Engineer

We are seeking a Senior R&D Engineer to join a neurovascular medical device start-up based in Orange County, CA. The CEO is seeking a hands-on R&D Engineer with expertise in neurovascular implant and catheter delivery system development. The Senior R&D Engineer will support product development projects for the EU and ROW markets.
 

Responsibilities:

• Designs and develops medical devices from concept through commercialization
• Creates, validates, and releases test methods, including sourcing equipment for measurements
• Supervises and performs pre-clinical testing, including in vivo testing
• Creates, validates, and releases test methods, including sourcing equipment for measurements
• Develops and qualifies processes and manufacturing procedures, including equipment qualification
• Defines and coordinates testing with outside test laboratories, including pre-clinical test labs

Qualifications:

• Bachelor's degree or advanced degree in Mechanical Engineering (or other engineering discipline)
• Minimum of 5 years of R&D experience in medical device mechanical design (ISO 13485 regulated environment)
• 2+ years of hands-on experience with neurovascular catheter/stent design and development
• Catheter manufacturing and process development experience
• medical device testing experience - executing test protocols, developing test methods.
• Experience in medical device manufacturing line support
• Experience with laser cutting, braiding and implant design