Are you an experienced, hands-on catheter engineer with broad device development and build capabilities? The talented engineer in this role will report to the Director of R&D and join an expanding developer of innovative systems that have successfully treated thousands with life threatening cardiac arrhythmias.
This position requires a self-starter who can play a key role in developing robust catheter designs for manufacturability, and bring new products through commercialization. Responsibilities include ideation and invention, solving unique technical challenges, conducting bench-top/preclinical testing to prove safety and efficacy, and development of manufacturing processes support of regulatory submissions. The design challenges require strong analytical and problem-solving skills, and detailed knowledge of the catheter build process. The Catheter Development Engineer will collaborate with a high performing, cross-functional team of technicians in R&D and Manufacturing Engineering.
Qualifications:
- BS, MS or equivalent experience in Plastics, Mechanical, Manufacturing or Biomedical Engineering.
- Extensive, successful commercial experience in the development and commercialization of complex catheter and disposables.
- Strong knowledge of catheter fabrication processes, such as melt bonding and lumen/balloon interface.
- Demonstrated ability to take projects from concept through product realization and process development.
- 3D CAD modeling such as SolidWorks is desired.
- Strong written and verbal communication skills. Ability to write clear reports, specifications, and proposals and effectively discuss them with a team from R&D, Manufacturing Engineering, Quality, Clinical, Marketing
- Working knowledge of regulatory requirements for medical devices.
- Basic understanding of statistics for design applications is desired.
- Exposure to the development of radio frequency ablation systems or electroporation systems is a plus.