Cardiac Catheter Development Engineer

Job Family:

Travel Required:

Clearance Required:

What You Will Do:

We are searching for a Cardiac Catheter Development Engineer with industry-based experience to support the development of minimally invasive, non-surgical cardiac catheter technologies. The selected individual will be supporting cardiovascular intervention research at the National Heart, Lung, and Blood Institute (NHLBI) through the provision of hands-on engineering support for the iterative design, prototyping, manufacturing, and testing of cardiovascular catheter devices and imaging algorithms. This is a full-time onsite role in Bethesda, MD.

• 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 maintaindesign 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).

What You Will Need:

• 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 intheMedicalDevice Manufacturing industryrequired.

• Experienceutilizingtechniques such as tipping, bonding, steering assemblies, sensor integration, leak/pressuretestingor similar.

• Experience with regulatory standards such as ISO 10555 (intravascular catheters), IEC 60601-1 (performance of medical electrical equipment), or comparable standards.

• Proficiencywith 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

What Would Be Nice To Have:

• 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.

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.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [email protected]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or [email protected]. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact [email protected]. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.