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Job Title: Catheter Development Engineer

Job Location: MA
Job Description:

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 
IDE application.  

Job Requirements
·	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 

Job Qualifications
·	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.

Other Job Information

City: Somerville
Salary Range:
Relocate: Yes

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