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Catheter Engineer - Awesome Benefits #1539

Details
Posted By:
kathy stark
Posting ID:
3803w2246
Location:
Boston Massachusetts
Telephone:
608 698 9505
Tags:
 employment 
Category:Engineering
Listing Type:Job
Employment:Full Time
Company:unknown

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Title: Catheter Engineer #1539

Location: Boston MA

Relocation: Yes(prefer local or no relo)

Company is a start-up medical device company developing innovative thermal therapies.. They seek a Catheter Development Engineer. Will be responsible for finalizing the design and fabrication methods for a steerable RF ablation catheter.

Job Requirements:
* Develop new catheter designs and fabricate prototype devices
* Specify various sub components 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 testing.

Job Qualifications:
* BS Degree in Mechanical, Biomedical or Materials Engineering
* 3 years experience designing and validating steerable catheters
* Familiarity with radio frequency 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 Microsofe office tools, expecially Word and Excel
* Strong writing and oral communication skills

Company offers competitive salary and excellent benefits, including a company-funded SEP-IRA and stock options.

Requirements:
1 BS Degree in Mechanical, Biomedical or Materials Engineering
2 3 years experience designing and validating steerable catheters
3 Familiarity with radio frequency ablation and fluid dynamics desirable
4 Experience using Solidworks
5 Experience operating in a highly regulated environment with exposure to ISO13485 and FDA standards.

Please fax your resume to 920-348-5001 for earliest consideration...Interviews are being scheduled NOW, and hiring this week! DON'T WAIT...contact me immediately!

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