R&D Catheter Engineer

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION

Our client is a privately held medical device company pioneering breakthrough catheter-based therapies in atrial fibrillation. The organization is rapidly scaling following the acquisition of a world-leading electrophysiology innovator, and is now advancing the next generation of a cardiac ablation system that integrates novel balloon, large-area, and pulsed-field ablation technologies.

The company currently has two catheters in active clinical trials
, including a first-in-human catheter undergoing full subsystem optimization and a complete shaft redesign
. With two upcoming IDE studies
, a planned CE Mark submission next year
, and acceleration toward commercial readiness in Europe, the need for strong, hands-on R&D execution has never been greater.

This is an opportunity to join a high-growth, mission-driven organization where engineers directly influence life-saving technologies and help expand global access to minimally-invasive AFib treatment. The environment is fast-paced, collaborative, and highly innovative — ideal for an engineer who thrives in true new product development (NPD).

We are seeking a hands-on, early-career R&D Catheter Engineer who will own the design and development of catheter subsystems and components and contribute across multiple active development programs.

• Own the design and development of multiple catheter subsystems and components across balloon, large-area, and next‑gen ablation platforms
• Drive new product development (NPD) activities, from concept through design iteration and verification
• Perform hands‑on prototyping, iterative builds, and bench testing
• Lead and support design of new catheter manufacturing processes, including assembly methods and process characterization
• Conduct process studies, design evaluations, and verification testing
• Execute tolerance analysis, material evaluation, and component selection activities
• Support biocompatibility evaluations, packaging development, and design‑control documentation
• Coordinate across Quality, Manufacturing, Operations, and Clinical counterparts as development progresses toward transfer
• Maintain detailed engineering documentation, DHF inputs, reports, and test protocols
• Contribute to a fast‑paced, startup‑minded culture requiring initiative, adaptability, and a strong “doer” mindset, and comfort working in a fast‑paced environment with shifting priorities

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering field
• 2–3 years of medical device experience with direct catheter experience
• Demonstrated hands‑on experience in new product development (NPD)
• Understanding of process development, quality systems, design controls, and development lifecycle deliverables
• Ability to work onsite in a highly collaborative and fast‑paced engineering environment

• Exposure to Pulsed Field Ablation (PFA), electrophysiology, or cardiac ablation technologies
• Strong prototyping, test execution, bench testing, and iterative design skills
• Experience with tolerance analysis, component selection, and process development
• Exposure to V&V test method development
• Prior experience at companies like Boston Scientific, Abbott EP, or other catheter-focused organizations
• Experience supporting design transfer or sustaining engineering activities tied to development

• Onsite in Marlborough, MA (5 days/week)

• Entry level

• Full-time

Medical Equipment Manufacturing