Staff R&D Engineer – Ablation Catheter System

Field Medical, Inc.; Carlsbad (CA); On-site; USD 150,000 - 240,000; Full time

Job summary

Field Medical, Inc. in Carlsbad, CA is seeking a senior mechanical/biomedical engineer to own portions of the FieldForce catheter program, including design, bench testing, and verification.

You will collaborate with system, preclinical, electrical, regulatory, and quality teams to ensure robust design deliverables on an ambitious timeline. You will drive manufacturability, engage in design reviews, and contribute to risk management and usability activities while maintaining rigorous design

Qualifications

• Hands-on catheter or interventional device development experience.
• Experience with design controls and regulatory requirements.
• Strong CAD and prototyping capability.
• Excellent written and verbal communication; able to author specs and test reports.

Responsibilities

• Design, prototype, and iterate catheter components including shaft construction, electrode assemblies, deflection mechanisms, and distal tip configurations.
• Work with materials 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.
• Own engineering deliverables within a phase-gated development process, from authoring and review through release and maintenance.
• Drive innovation and ensure products meet manufacturability and cost targets.
• Research, identify, and advise on new vendors, materials, and processes.
• Design and execute bench test protocols for catheter characterization.
• Lead hipot, dielectric withstand, and electrical isolation testing for high-voltage components.
• Conduct and document preclinical and animal lab testing; draft test reports for DHF.
• Troubleshoot test findings and drive root-cause analysis.

Skills

Catheter development

Design controls

DHF documentation

Communication skills

Test protocol writing

Education

B.S. in Mechanical Engineering, Biomedical Engineering, or related field

Tools

SolidWorks

Minitab

JMP

Job description

Founded in 2022, Field Medical is a clinical-stage medical technology company committed to advancing pulsed field ablation (PFA) solutions for complex cardiac arrhythmias. Its FieldForce Ablation System integrates a focal catheter design with proprietary FieldBending energy designed to safely deliver efficient, precise ablation with the goal of improving outcomes in ventricular and atrial arrhythmia treatment. In 2024, Field Medical earned Breakthrough Device Designation and gained entry into the FDA TAP Pilot Program for its ventricular tachycardia indication. In October 2025, the VCAS trial was published in Circulation.

The FieldForce Ablation System is a focal, contact-sensing PFA system built on proprietary FieldBending™ technology to deliver targeted, high-intensity electric fields using a novel pulsed energy delivery strategy. Designed to support both atrial and ventricular ablation, the system serves as a universal ablation platform for the heart and beyond. The FieldForce system is designed to enable targeted and tailored ablation treatment while platform features focus on procedural efficiency.

About the Role:

This is a high-impact engineering role at a fast-moving medical device startup. For someone looking for independence and flexibility in a fast timeline environment with clear scope and deliverables. This individual will own portions of the program, working across catheter design, bench and preclinical testing, and design verification — collaborating closely with our system, preclinical, electrical, regulatory, and quality teams.

Your Responsibilities Will Include:

• 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.
• Own engineering deliverables within a phase-gated development process, from authoring and review through release and maintenance.
• Drive innovation and ensure products achieve best-in-class performance while promoting manufacturability and meeting cost targets.
• Research, identify, and advise on new vendors, materials and/or processes

Verification & Testing

• Design and execute bench test protocols for catheter characterization: force sensing, torque/push-ability, deflection, tip force, and electrical performance
• Lead and support hipot, dielectric withstand, and electrical isolation testing for high-voltage catheter components and associated interfacing
• Conduct and document preclinical and animal lab testing; analyze results and draft test reports for design history file (DHF)
• Troubleshoot test findings 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 10993, ISO 10555, ISO 11135, 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. in Mechanical Engineering, Biomedical Engineering, or related field
• 8+ 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 and ownership with CAD (SolidWorks preferred), including model and drawing release.
• Familiarity with design controls, DHF documentation, and FDA QSMR / 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 Carlsbad and able to travel regularly for supplier visits, physician partnerships, or case support.

Preferred Qualifications:

• M.S. in Mechanical Engineering, Biomedical Engineering, or related field
• 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 usability review with interventionalists, technicians and EP and/or cath lab staff
• Exposure to force sensing, electromagnet, 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 or understanding, with proficiency in tools such as Minitab or JMP.
• Demonstrated hands on mechanical design expertise, preferably with single use vascular devices and catheter development, prototyping, and manufacturing.

Location & Travel Requirements:

• Onsite Carlsbad, CA
• Willingness to travel up to 25%

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.