Catheter Development Engineer

Job Family:
Systems Engineering (Digital)

Travel Required:
None

Clearance Required:
Ability to Obtain NACI

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 experience in a research and/or laboratory setting.
• Has 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"; candidates must obtain approved adjudication of their PUBLIC TRUST prior to onboarding with Guidehouse. Candidates with an ACTIVE PUBLIC TRUST or SUITABILITY are preferred.

What Would Be Nice To Have:

• 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.
• A background in clean-room assembly or micro-fabrication is preferred.

#LI-NDI

The annual salary range for this position is $98,000.00-$163,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• 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

About Guidehouse

Guidehouse is an Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

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