Guidehouse
Scientific Research & Analysis
CardiacCatheterDevelopmentEngineer
“Cardiac Catheter Development Engineer at Guidehouse. Skills: Cardiac catheter development, Medical device manufacturing, Prototyping, Regulatory standards. Support engineering R&D. Design catheter components”
What You'll Achieve.
Support development of minimally invasive cardiac catheter technologies; Prepare reports for regulatory submissions
Industry & Context.
Ability to Obtain Public Trust, Federal or DoD "public trust" clearance
What They're Looking For.
Must Have
Bachelor’s degree in biomedical, mechanical, materials, electrical engineering, or related field, A minimum of FOUR (4) years of active medical device development experience, at least TWO (2) years of direct cardiac catheter hands-on manufacturing and prototyping experience in the Medical Device Manufacturing industry required, Experience utilizing techniques such as tipping, bonding, steering assemblies, sensor integration, leak/pressure testing or similar, Experience with regulatory standards such as ISO 10555 (intravascular catheters), IEC 60601-1 (performance of medical electrical equipment), or comparable standards, Proficiency with Computer-Aided Design (CAD) software such as SolidWorks or similar tools, Must be able to obtain and maintain a Federal or DoD "public trust"
Nice to Have
Familiar with mechanical and electrical test equipment, flow loops, simulated-use rigs and similar equipment, Deep material science knowledge beneficial, Experience in the development of Electrophysiology (EP) ablation catheters utilizing pull-wire mechanisms or tip temperature control, Prior involvement in 510(k), Premarket Approval (PMA), or EU Medical Device Regulation (MDR) submissions is valuable, A background in clean-room assembly or micro-fabrication is preferred, active public trust or suitability
What You'll Do.
Support engineering R&D
Design catheter components
Integrate electronic components
Lead prototype fabrication
Develop validation protocols
Conduct data analysis
Generate design history files
Contribute to continuous improvement
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