Cardiac Catheter R&D Engineer — Onsite Bethesda

US132 Guidehouse Digital, LLC; Bethesda (MD); On-site; USD 98,000 - 163,000; Full time

Benefits offered by this job

Medical, Rx, Dental & Vision Insurance

401(k) Retirement Plan

Tuition Reimbursement

Job summary

Guidehouse is seeking a Cardiac Catheter Development Engineer to support the design, prototyping, testing, and validation of next‑generation cardiovascular catheter devices and imaging algorithms. The role is based onsite in Bethesda, MD, with hands-on fabrication, regulatory alignment, and documentation in ISO 13485‑compliant environments.

The candidate should have 4+ years in medical device development, including 2+ years in cardiac catheter hands‑on work, CAD/ SolidWorks proficiency, and

Qualifications

• Bachelor's degree in biomedical, mechanical, materials, or electrical engineering.
• Minimum 4 years of active medical device development experience with at least 2 years of direct cardiac catheter hands-on manufacturing/prototyping.
• Experience with tipping, bonding, steering assemblies, sensor integration, leak/pressure testing.
• Familiarity with ISO 10555, IEC 60601-1 or equivalent standards.

Responsibilities

• Support R&D for next-generation catheter systems, guidewires, and electronics.
• Lead prototype fabrication with ISO 13485 compliant documentation.
• Develop and execute validation protocols per ISO/IEC standards.
• Contribute to design history files, FMEAs, hazard analyses, and biocompatibility matrices.

Skills

Medical device development

Prototyping

Regulatory awareness

Education

Bachelor’s degree in biomedical, mechanical, materials, or electrical engineering

Tools

SolidWorks

Lab equipment operation

Job description

Guidehouse is seeking a Cardiac Catheter Development Engineer to support the design, prototyping, testing, and validation of next‑generation cardiovascular catheter devices and imaging algorithms. The role is based onsite in Bethesda, MD, with hands-on fabrication, regulatory alignment, and documentation in ISO 13485‑compliant environments.

The candidate should have 4+ years in medical device development, including 2+ years in cardiac catheter hands‑on work, CAD/ SolidWorks proficiency, and