Catheter Development Engineer

Job Family:

Travel Required:

Clearance Required:

What You Will Do:
We are currently searching for a Cath 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 componentsthermocouples RF electrodes phased-array coils strain gauges and microconnectorsinto 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:

• Bachelors 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.

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

• 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 EmployerProtected 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- or via email at . 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 @ or . 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.

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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.