We are searching for a Director of Catheter Development for a highly regarded, rapidly growing, Class III medical devices company located in Irvine, CA. The Director of Catheter Development will lead cross functional teams in the development of balloon catheters. This position is open at both the manager and director levels.
This well funded, and rapidly growing company is expected to go public next year.
Requirements for the Director of Catheter Development:
Bachelor’s degree in mechanical engineering or biomedical engineering; advanced degree preferred
8+ years experience developing Class III medical devices with at least 4 years developing cardiovascular balloon catheters
Strong working knowledge of the balloon catheter space, and an understanding of electrophysiology principles
Experience writing and verifying specifications, designing test fixtures, test processes.
Experience developing and mentoring product development teams
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 Director of Catheter Development:
Develop new balloon catheter product concepts and products
Work with physicians and subject matter experts to develop design needs and specifications for device prototype
Work with executive leadership to develop strategic product development plans
Develop product design and manufacturing processes
Prepare technical documentation, manage appropriate design history files
Work with cross functional teams including regulatory, quality and clinical
Direct the specification and testing of new materials and designs
