Sr. R&D Engineer - Ablation Catheter Systems

Company Overview:

Founded in 2022, Field Medical Inc. is a medical device company advancing next-generation pulsed field ablation (PFA) technologies for the treatment of cardiac arrhythmias.

Field Medical’s flagship innovation, the FieldForce™ Ablation System, is the first contact force focal PFA catheter system designed specifically for ventricular use. By delivering brief, high-intensity electric fields to target cardiac tissue without thermal damage, the system represents a novel approach to treating some of the most challenging arrhythmias. The company’s proprietary FieldBending™ technology enables precise and large-volume lesion creation, supporting a broad range of electrophysiology applications.

About the Role:

Field Medical Inc. is developing the FieldForce Ablation Catheter System, a Class III cardiac pulsed field ablation (PFA) device incorporating integrated electromagnetic location and force sensing technology. We are seeking a Senior R&D Engineer to contribute to the design, development, and verification of our next-generation ablation catheter as we advance through IDE submission, into clinical trials and beyond PMA approvals.

This is a high-impact engineering role at a fast-moving medical device startup requiring independence and flexibility through a fast timeline with clear scope and deliverables established. This individual will work across catheter design, bench and preclinical testing, and design verification — collaborating closely with our preclinical, electrical, regulatory, and quality teams.

Your Responsibilities Will Include:

Catheter Design & Development
Design, prototype, and iterate on catheter components including shaft construction, electrode assemblies, deflection mechanisms, and distal tip configurations
Work with materials (extruded polymers, reflow, braided constructs, polyurethanes, potting, fiber optic integration) to achieve mechanical performance targets
Collaborate on integration of fiber optic force sensing elements into catheter architecture
Maintain and update design documentation including drawings, BOMs, and engineering change orders in a design-controlled environment.
Demonstrating PDP and TDP system knowledge through the delivery of high quality and high impact deliverables including generating, reviewing, submitting, and maintaining engineering documentation.
Drive innovation and ensure products achieve best-in-class performance while promoting manufacturability and meeting cost targets.
Research and advise on new vendors, materials and/or processes

Verification & Testing
Design and execute bench test protocols for catheter characterization: force sensing, torque/pushability, deflection, tip force, and electrical performance
Support hipot, dielectric withstand, and electrical isolation testing for high-voltage catheter components
Conduct and document preclinical and animal lab testing; analyze results and draft test reports for design history file (DHF)
Troubleshoot test failures and drive root cause analysis and corrective actions

Cross-Functional Collaboration
Interface with regulatory and quality teams to ensure design outputs align with IDE submission requirements (21 CFR 812, ISO 14971, ISO 10555, IEC 60601-1)
Contribute to build planning and production of catheter prototypes for bench, preclinical, and DV test campaigns
Interface with hardware, electrical and software teams to ensure design outputs align with system requirements.
Participate in design reviews, FMEA development, and usability engineering activities

Required Qualifications:
B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, or related field
3–6 years of experience in medical device R&D, with hands-on catheter or interventional device development, testing, quality and regulatory requirements
Demonstrated experience with cardiac or neuro catheter and/or sheath construction: braided shafts, polymer extrusions, tip assemblies, micro components and processes, deflection mechanisms.
Proficiency in mechanical design and tolerance analysis, including drawings; experience with CAD (SolidWorks preferred)
Familiarity with design controls, DHF documentation, and FDA QSR / ISO 13485 requirements. Proven execution and release in a phase gate-based environment.
Strong written and verbal communication skills; ability to author test protocols, reports, and design documentation independently. Ability to build and present results of studies when needed.
Must work onsite.

Preferred Qualifications:
Experience with cardiac ablation catheters, electrophysiology devices, or PFA/RF ablation systems. Direct experience in the cardiovascular space with tools and anatomy.
Experience with human factors and useability review with interventionalists, technicians and EP and/or cath lab staff
Exposure to force sensing, fiber optic sensing, or other integrated sensor technologies in catheter platforms
Familiarity with high-voltage component testing (hipot, dielectric) and electrical characterization of catheter assemblies
Experience supporting IDE or PMA submissions and working with preclinical/animal lab data
Knowledge of sterilization processes (ETO preferred) and sterile packaging validation
Strong statistical analysis skills, with proficiency in tools such as minitab
Demonstrated hands on mechanical design expertise, preferably with single use vascular devices and catheter development.

Location & Travel Requirements:

On-site, Carlsbad, CA
Willingness to travel up to 10%

Field Medical, Inc. is proud to be an equal opportunity employer. We are committed to creating an inclusive and respectful workplace where everyone has the opportunity to thrive. All employment decisions, including recruitment, hiring, assignments, promotions, compensation, and other aspects of employment, are made without regard to race, color, religion, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, age, disability, veteran status, or any other protected status.

At Field Medical, we believe that diverse perspectives fuel innovation—and we’re proud to foster a culture where all voices are valued.
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