Support engineering research and development efforts focused on next-generation catheter systems, guidewires, and accessory electronics. 

Design catheter components (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, radiofrequency (RF) electrodes, phased-array coils, strain gauges, and microconnectors) into medical devices including development of wiring harnesses and custom interface assemblies. 

Lead prototype fabrication using advanced laboratory equipment (laser cutters, braid machines, reflow systems, coil winders) ensuring all builds are thoroughly documented and in compliance with International Organization of Standardization (ISO) 13485 standards. 

Develop and execute validation protocols aligned with ISO 10555, International Electrotechnical Commission (IEC) 60601-1, and American Society for Testing and Materials (ASTM) standards 

Conduct comprehensive data analysis and preparation of reports for regulatory submissions. 

Generate and maintain design history files, Failure Mode and Effects Analysis (FMEAs), hazard analyses, and biocompatibility matrices. 

Contribute to continuous improvement initiatives associated with tooling, design processes, and standard operating procedures (SOPs).

Bachelor’s degree in biomedical, mechanical, materials, electrical engineering, or related field. 

A minimum of FOUR (4) years of active medical device development experience withat least TWO (2) years of direct cardiac catheter hands-on manufacturing and prototyping experience intheMedical Device Manufacturing industry required. 

Experienceutilizingtechniques such as tipping, bonding, steering assemblies, sensor integration, leak/pressure testingor 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"; candidates must obtain approved adjudication of their public trust prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred

Familiar with mechanical and electrical test equipment, flow loops, simulated-userigsand similar equipment. 

Deep material science knowledge beneficial.

Experience in the development of Electrophysiology (EP) ablation cathetersutilizingpull-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.