Sr. System Mechanical Engineer

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:

We are seeking a highly skilled and detail-oriented Sr. System Mechanical Engineer to serve as the lead mechanical engineer and owner of the mechanical design for the capital equipment (generator) that the company is developing. Building on an existing design, this person will drive design improvements, problem solving, technical investigations as needed, cost reduction, and design for manufacturing to ensure the product is robust, manufacturable, and ready for production. This role requires strong technical leadership and close coordination across engineering, quality, manufacturing, supply chain, and external partners.

This person will guide and direct external support engineers and drafters through detailed design execution, design and configuration control, and transfer to production of new and revised designs. The role includes creating and directing the creation of drawings, bills of materials, specifications, engineering analyses such as tolerance stack-ups and heat dissipation simulations, and technical reports, as well as reviewing and releasing these deliverables.

Your Responsibilities Will Include:

• Own the mechanical design of the company’s capital equipment generator, including overall design architecture, detailed component design, and integration of subassemblies.
• Lead design improvements to an existing baseline design to improve performance, reliability, manufacturability, serviceability, and cost.
• Drive structured problem solving and technical investigations related to design issues, failures, and performance gaps, and document conclusions and recommended actions.
• Apply design for manufacturing and cost reduction principles to mature the design for scalable production.
• Guide and direct external support engineers and drafters in the creation and refinement of parts, assemblies, drawings, and related design documentation.
• Establish, maintain, and enforce design and configuration control for mechanical components, assemblies, and associated documentation.
• Create and direct the creation of detailed drawings, bills of materials, specifications, engineering analyses, and technical reports.
• Perform or oversee engineering analyses such as tolerance stack-ups, thermal or heat dissipation simulations, and other studies needed to support design decisions.
• Review and release drawings, BOMs, specifications, analyses, and reports in accordance with company processes and design control requirements.
• Partner cross-functionally with manufacturing, quality, supply chain, and other engineering disciplines to support prototype builds, design verification, issue resolution, and transfer to production.
• Support development of DHF and DMR content as applicable to the mechanical design and product realization process.
• Communicate technical risks, tradeoffs, progress, and recommendations clearly to management and cross-functional stakeholders.
• Lead cross-functional alignment to define system specifications, requirements, architecture, performance, and usability objectives.
• Plan and conduct system integration, proof-of-design testing, and system and sub-system verification and validation activities.
• Build simulations and models of system functions, and lead feasibility studies.
• Perform measurements, create engineering designs, develop plans, and maintain laboratory notebooks for all work.
• Conduct testing (bench, V&V, in vivo), develop and utilize test protocols, and generate written reports.
• Act as a liaison between external vendors and internal cross-functional teams.
• Travel to customer sites, domestic and international, to gather VOC, perform testing, and support troubleshooting activities.
• Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering or equivalent is required; advanced degree is a plus.
• 8 years of mechanical engineering experience in product development, including responsibility for complex assemblies or capital equipment, preferably in regulated industries.
• Demonstrated experience owning mechanical designs from concept or early design through design refinement, release, and transfer to production.
• Strong experience with detailed mechanical design, drawings, bills of materials, specifications, tolerance analysis, and design documentation.
• Experience guiding the work of other engineers, contractors, or drafters and driving execution without direct people management authority.
• Experience with capital equipment or generator design involving structural, thermal, packaging, or electro-mechanical considerations.
• Hands-on experience with root cause investigation, problem solving, design improvements, and design for manufacturing.
• Experience with design control, engineering change processes, and configuration management in a regulated product development environment.
• Strong written and verbal communication skills, with the ability to review and approve technical deliverables and work effectively across cross-functional teams.
• Experience in medical device, life sciences, or other highly regulated product development environments.
• Proficiency with 3D CAD tools and creation or review of detailed manufacturing drawings.
• Experience performing or reviewing tolerance stack-up analyses, thermal analyses, and related engineering simulations.
• Familiarity with transfer to production, supplier engagement, and sustaining engineering activities.
• Experience with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA).

Preferred Qualifications:

• Experience in the medical device or aerospace industries
• Knowledge of medical device electrical standards such as the IEC 60601 family of standards

Location & Travel Requirements:

• In-Person in Carlsbad, CA
• Willingness to travel up to 25%
• The job requires work with multiple time zones around the world and a flexible work schedule.

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.