Guidehouse

Systems Engineering

CatheterDevelopmentEngineer

$98–163k Bethesda, Maryland, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Catheter Development Engineer at Guidehouse. Skills: Catheter development, Design and testing, Medical device integration, Regulatory compliance. Performing scientific and technical services in support of research. Working on iterative design and testing of catheter devices and imaging algorithms”

Industry & Context.

Systems Engineering
Problems you'll solve

Iterative design and testing; Sensor integration; Continuous improvement initiatives

Eligibility Requirements

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 experience in a research and/or laboratory setting, Demonstrated hands-on expertise in catheter development, including tipping, bonding, steering assemblies, sensor integration, and leak/pressure testing, Experience with ISO 10555, IEC 60601-1, or comparable standards, Proficiency with CAD (SolidWorks or equivalent), Familiarity with mechanical and electrical test equipment, flow loops, and simulated-use rigs, Must be able to OBTAIN and MAINTAIN a Federal or DoD "PUBLIC TRUST"

Nice to Have

Candidates with an ACTIVE PUBLIC TRUST or SUITABILITY are preferred, Preferred experience in interventional cardiology catheters, EP ablation catheters, pull-wire mechanisms, or tip temperature deep material science, Prior involvement in 510(k), PMA, or EU MDR submissions, A background in clean-room assembly or micro-fabrication is preferred

What You'll Do.

Performing scientific and technical services in support of research

Working on iterative design and testing of catheter devices and imaging algorithms

Supporting engineering research and development efforts focused on next-generation catheter systems

and accessory electronics

Designing catheter components including shafts

steering and deflection mechanisms

and sensor integration

Integrating complex electronic components into medical devices

including the development of wiring harnesses and custom interface assemblies

Leading prototype fabrication using advanced laboratory equipment

Ensuring all builds are thoroughly documented in compliance with ISO 13485 standards

Developing and executing validation protocols aligned with ISO 10555

Preparing reports for regulatory submissions

Generating and maintaining design history files

and biocompatibility matrices

Contributing to continuous improvement initiatives in tooling

and standard operating procedures (SOPs)

How You'll Work.

Team & Collaboration

Supporting research by the Division of Intramural Research, in the National Heart Lung and Blood Institute

Communication Scope

Preparation of reports for regulatory submissions

Process & Methodology

Generating and maintaining design history files, FMEAs, hazard analyses, and biocompatibility matrices

Full Job Description

**_Job Family_ :** Systems Engineering ** _Travel Required_ :** None ** _Clearance Required_ :** Ability to Obtain Public Trust ** _What You Will Do_ :** We are currently searching for a Catheter Engineer. The role will be performing scientific and technical services in support of research by the Division of Intramural Research, in the National Heart Lung and Blood Institute in cardiovascular intervention. The individual will be working on iterative design and testing of catheter devices and imaging algorithms. This is a full-time opportunity supporting the NHLBI office located in Bethesda, MD. * Support engineering research and development efforts focused on next-generation catheter systems, guidewires, and accessory electronics. * Design catheter components including shafts, distal tips, steering and deflection mechanisms, and sensor integration using advanced materials such as polymers, alloys, braid/wire reinforcements, adhesives, and coatings. * Integrate complex electronic components—thermocouples, RF electrodes, phased-array coils, strain gauges, and microconnectors—into medical devices, including the development of wiring harnesses and custom interface assemblies. * Lead prototype fabrication using advanced laboratory equipment (e.g., laser cutters, braid machines, reflow systems, coil winders), ensuring all builds are thoroughly documented in compliance with ISO 13485 standards. * Develop and execute validation protocols aligned with ISO 10555, IEC 60601-1, and ASTM standards, including comprehensive data analysis and preparation of reports for regulatory submissions. * Generate and maintain design history files, FMEAs, hazard analyses, and biocompatibility matrices, while contributing to continuous improvement initiatives in tooling, design processes, and standard operating procedures (SOPs). **_What You Will Need_ :** * Bachelor’s degree in Biomedical, Mechanical, Materials, Electrical Engineering, or related field. * A minimum of FOUR (4) years of experi

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