Catheter Engineer

Guidehouse•Bethesda, MD

1d•$65,000 - $108,000

About The Position

We are currently searching for a Catheter Engineer. The person in this role will be performing scientific and technical services in support of cardiovascular intervention research by the Division of Intramural Research, in the National Heart Lung and Blood Institute. 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).

Requirements

Bachelor’s degree in Biomedical or Mechanical Engineering, or related field with at least TWO (2) years of laboratory related research Or Master’s degree in lieu of experience
Proficiency with CAD (SolidWorks or equivalent).
Familiarity with mechanical and electrical test equipment
Demonstrated experience with device prototype development
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

Nice To Haves

Preferred experience in interventional cardiology catheters, EP ablation catheters, pull-wire mechanisms, or tip temperature control; deep material science knowledge; prior involvement in 510(k), PMA, or EU MDR submissions.
Experience with ISO 10555, IEC 60601-1, or comparable standards.
A background in clean-room assembly or micro-fabrication is preferred

Responsibilities

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).

Benefits

Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Parental Leave
401(k) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus