We are searching for a Senior R&D Engineer with catheter development experience for a highly regarded, rapidly growing, Class III medical devices company located in Irvine, CA. The Senior R&D Engineer will lead cross functional teams in the development of balloon catheters.
Requirements for the Senior R&D Engineer – Catheters:
Bachelor’s degree in engineering, preferably mechanical engineering or biomedical engineering; advanced degree preferred
4+ years experience developing Class III medical devices with at least 2 years developing cardiovascular or peripheral catheters
Experience writing and verifying specifications, designing test fixtures, test processes.
Working knowledge of standard medical device manufacturing equipment and processes
Proficiency in SolidWorks
Strong communication skills, oral, written and electronic
Strong statistical and documentation skills
Responsibilities of the Senior R&D Engineer – Catheters
Develop new balloon catheter product concepts and products
Work with physicians and subject matter experts to develop design needs and specifications for device prototype
Develop product design and manufacturing process development
Prepare technical documentation, manage appropriate design history files
Direct the specification and testing of new materials and designs