Irvine, CA

Description

Support and lead teams in the development of medical device products, including writing or verifying specifications, developing product process, designing fixtures, testing processes, equipment and raw materials to ensure the concepts and/or prototypes meet their requirements.

Job Responsibilities

• Develop new product concepts and products.
• Perform engineering design and process development.
• Generate intellectual property, write invention disclosures.
• Supervise technicians, specialists, and associate engineers.
• Specify and/or direct the specification and testing of new materials and designs.
• Confer with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems and develop designs.
• Largely self-directed, capable of meeting project goals with minimal supervision.
• Collaborate with physicians and external experts.

Skills

•  Applies fundamental and advanced engineering principles, concepts and techniques to solve -complex problems related to product development.
• Design and development of medical devices.
• Reading and preparing technical documentation.
• Working knowledge of standard machine shop equipment and processes and medical device manufacturing equipment and processes.
• Knowledge of medical and technical development.
• Computer skills including Word, Excel etc.
• Communication and Presentation Skills
• CAD proficiency (Solidworks expertise required).
• 3D printing and design for Injection Molding

Pre-requisites/Job Experience

• BS degree or related equivalent.
• 8+ years engineering experience; 8+ years of related medical device experience. 5+ years with
• R&D experience.
• Technical Lead experience.
• Early Phase Class II or Class III medical device design experience.
• Catheter systems
• Balloon Catheter Design a plus
• Nitinol Experience a plus
• Patents a plus