Sr. Systems Engineer

Field Medical; Carlsbad (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Field Medical in Carlsbad, CA is seeking a Sr. Systems Engineer to lead systems engineering across new medical device development, ensuring DHF/DMR readiness, FDA compliance, and cross-functional alignment with engineering, quality, regulatory, and clinical teams.

This role emphasizes project planning, design reviews, test and V&V, and documenting specifications and analyses, with travel up to 25% and no direct reports.

Qualifications

• Bachelor’s degree in Mechanical or Electrical Engineering required.
• 7+ years engineering experience with medical devices.
• At least 3 years leading cross-functional teams.
• 3+ years systems engineering for multidisciplinary products (software/hardware).
• Experience with development processes and technical documentation.
• Knowledge of software development and programming for analysis tools.

Responsibilities

• Understand customer needs and write specifications for the system and sub-systems.
• Collaborate with SMEs to define and document system architecture and top-level design.
• Support technical designers in their design activities and verify fit of the design to system requirements.
• Conduct and review scientific analysis of the system (physical, hardware, software, algorithms, sensors, etc.) and related engineering activities to validate simulations and system design.
• 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.
• Recommend and enforce design compliance with electrical standards for medical devices.
• Conduct software evaluations, reviews, and system analyses.
• 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.

Skills

Cross-functional leadership

Systems engineering

Software & hardware integration

Documentation & processes

Software development basics

Education

Bachelors in Mechanical/Electrical Engineering

Tools

Software development tools

Data analysis tools

Job description

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. Systems Engineer to lead systems engineering activities across our product development efforts. This person will be responsible for engineering and scientific DHF development, guiding internal R&D projects, and leading V&V efforts across the broader development team. While this role does not include direct people management, it does require strong cross-functional leadership to drive alignment across engineering, quality, regulatory, clinical, and other partner functions. The systems engineering function is responsible for helping prepare for international submissions and ensuring compliance with FDA requirements and applicable international standards.

This role encompasses project planning, technical specification development, test and test tool development, workstream coordination, tracking progress across development and engineering teams, and development of DHF and DMR records.

Your Responsibilities Will Include:

• Understand customer needs and write specifications for the system and sub-systems.
• Collaborate with SMEs to define and document system architecture and top-level design.
• Support technical designers in their design activities and verify fit of the design to system requirements.
• Conduct and review scientific analysis of the system (physical, hardware, software, algorithms, sensors, etc.) and related engineering activities to validate simulations and system design.
• 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.
• Recommend and enforce design compliance with electrical standards for medical devices.
• Conduct software evaluations, reviews, and system analyses.
• 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.
• Communicate business-related issues or opportunities to management as appropriate.
• 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, Electrical Engineering, or equivalent is required.
• 7+ years of engineering experience, including technology or product development responsibility in medical devices, along with at least 3 years of experience providing technical leadership on cross-functional teams.
• 3+ years of experience in systems engineering for multidisciplinary products involving software and hardware is required.
• Demonstrated ability to lead cross-functional alignment and drive execution without direct people management authority.
• Experience with development processes and technical documentation writing is required.
• Knowledge of and experience with software development and programming for tools and data analysis is required.

Preferred Qualifications:

• Experience with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) and software version control
• Experience in the medical device or the aero-space 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 to work with multiple time zones around the world and have 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.