R&D Catheter Engineer
Listed on 2026-01-17
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Engineering
Biomedical Engineer, Medical Device Industry
Description
Onsite in Marlborough, MA
Our client is a fast-growing medical device organization advancing catheter-based therapies for atrial fibrillation, with two catheters in clinical trials and preparation for major IDE studies and a CE Mark submission. Following the acquisition of a world-leading electrophysiology innovator, the combined team is developing a next-generation ablation system integrating balloon and large-area technologies. The company offers a high-growth setting where engineers make direct contributions to products that expand access to minimally invasive AFib treatment.
This is a contract to hire opportunity. Applicants must be willing and able to work on a w2 basis and convert to FTE following contract duration. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $50.00 to $80.00/hr. w2
Responsibilities- Own the design and development of multiple catheter subsystems and components across balloon, large-area, and next-generation ablation platforms.
- Drive new product development 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 with initiative, adaptability, and a doer mindset.
- 2–3 years of medical device experience with direct catheter experience.
- Demonstrated hands‑on experience in new product development.
- Understanding of process development, quality systems, design controls, and development lifecycle deliverables.
- Ability to work onsite in a fast‑paced and collaborative engineering environment.
- Exposure to pulsed field ablation, electrophysiology, or cardiac ablation technologies preferred.
- Strong prototyping, test execution, bench testing, and iterative design skills preferred.
- Experience with tolerance analysis, component selection, and process development preferred.
- Exposure to V&V test method development preferred.
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering field.
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