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Cardiac Catheter Development Engineer

Guidehouse -
Bethesda, MD

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Job Details

Full-time
$98,000 - $163,000 a year

Benefits

Commuter assistance
Health savings account
AD&D insurance
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Parental leave
Employee assistance program
Vision insurance
Life insurance
Referral program

Qualifications

Fabrication
Accreditation standards (regulatory compliance area)
ISO standards
CAD design (engineering design task)
Design engineering
Prototype creation
Biomedical regulatory compliance
Research regulatory compliance
Biomedical manufacturing processes
Medical devices electrical engineering expertise
Legal compliance
Manufacturing company experience
Prototypes

Full Job Description

Job Family:

Scientific Research & Analysis

Travel Required:

None

Clearance Required:

Ability to Obtain Public Trust

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 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).

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.

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

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.

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.

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.

Apply Now

Refine Your Search

Development Test Engineer jobs

Cardiac Catheter Development Engineer

Sr Mechanical Engineer

Civil Engineer, PE Site Development

Civil Engineer EIT - Site Development

Product Design & Development Engineer

EPMS Engineer

SIM Operations Engineer

Test Engineer

Field Service Engineer

FPGA/DSP Design Engineer (VHDL/Verilog)

Metallurgical Engineer

Test Engineer II/III

Research Engineer

Welding Engineer

Controls Engineer

Applications Engineer II

Mechanical Engineer

Electrical Transmission Line Design Engineer

MBSE Systems Engineer

Rocket Booster SME

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