Menlo Park, CA

Senior Research & Development Engineer (Catheter))

* _Key contributor on development of next generation RheOx Catheter used with the RheOx Catheter for the management of pulmonary diseases._
* _Providing technical support to Quality for CAPA investigations, complaint and catheter failure investigations._
* _Provide sustaining engineering support to Quality and Operations on existing commercialized RheOx system._
* _Providing technical support to manufacturing and operations through the catheter development process_
* _Working with Quality, Clinical and Regulatory personnel to support quality management system design controls regulatory submissions; strong communication skills a must (verbal and written)_
* _Working closely with and managing external contract manufacturer on detail design and process development of next generation RheOx Catheter._
* _Experience developing state-of-the-art catheters for therapeutic energy delivery in electrosurgical systems or similar medical equipment (2+ years less experience considered for individuals with advanced degrees)._
* _Strong working knowledge of 3D modeling software such as SolidWorks to generate models, design drawings, and assemblies._
* _Strong working knowledge of medical device design controls and quality systems_
* _Ability to work and contribute effectively in a team environment while also being able to work and solve problems working independently when necessary._
* _Familiarity with design control processes and testing required for development of sterile single use catheters (e.g., sterilization validation, biocompatibility, transit and mechanical)_
* _Knowledge and domestic and international regulations affecting medical devices_
* _Ability to adapt quickly in a fast-paced, evolving company and operate with a high sense of urgency_
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