Job Title: Catheter Development Engineer
Job Location: MA
We seek a Catheter Development Engineer. You will be responsible for finalizing the
design and fabrication methods for a steerable RF ablation catheter. You will work
closely with company founders and with clinical collaborators at leading EP labs
around the country to design a catheter to deliver Thermedical’s novel SERF™
Ablation therapy. You will specify the catheter body and steering mechanisms, work
with vendors refine the subcomponents, and develop the fabrication process. After
receiving feedback from our clinical collaborators you will refine the design. You will
then carry out the builds for verification and validation, and you will develop test
methods and fixtures, and carry out and document the tests required to support our
· Develop new catheter designs and fabricate prototype devices.
· Specify various subcomponents including plastic extrusions and
injection molded steering mechanisms.
· Design and develop new processes, tooling and packaging for catheter
fabrication and manufacture.
· Prepare plan for Verification and Validation in accordance with
company documentation and FDA and industry standards
· Carry out ex vivo, preclinical and clinical performance testing.
· Document test results for inclusion into regulatory submissions (510
(k), IDE, PMA).
· Develop Bills of Materials and Assembly Instructions and transfer
design to Manufacturing.
· Travel to collaborating clinical institutions to carry out performance
· BS Degree in Mechanical, Biomedical or Materials Engineering.
· 3 years experience designing and validating steerable catheters.
· Familiarity with radiofrequency ablation and fluid dynamics desirable.
· Experience using Solidworks.
· Knowledge of FDA, IEC and UL standards relating to medical devices.
· Familiarity with operating in a highly regulated environment with
exposure to ISO13485 and FDA standards
· Experience with Microsoft office tools, especially Word and Excel.
· Strong writing and oral communication skills.
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