Senior Systems Engineer, Medical Devices & V&V Lead

Field Medical; Carlsbad (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Field Medical is seeking a Sr. Systems Engineer in Carlsbad, CA to lead systems engineering across product development. You will guide DHF/DMR development, coordinate with R&D, quality, regulatory, and clinical teams, and ensure FDA compliance and international standards.

The role requires a hands-on leader who can plan technical specifications, develop test tools, track progress, and drive V&V activities across multiple disciplines. Domestic and international travel may be required.

Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, or equivalent.
• 7+ years engineering experience with medical devices, including 3+ years leading cross-functional teams.
• 3+ years of systems engineering for multidisciplinary products with software and hardware.
• Proven ability to lead cross-functional alignment without people management authority.
• Experience with development processes and technical documentation writing.
• Knowledge of software development and data analysis.

Responsibilities

• Understand customer needs and write system specifications.
• Define system architecture with SMEs and document top-level design.
• Support design activities and verify fit to requirements.
• Conduct and review analyses to validate simulations and design.
• Lead cross-functional alignment on specifications, performance, and usability.
• Plan system integration, PoD testing, and V&V activities.
• Build simulations/models and lead feasibility studies.
• Create engineering designs and maintain lab notebooks.
• Conduct bench, V&V, and in vivo testing with protocols and reports.
• Ensure compliance with electrical standards for medical devices.
• Perform software evaluations and system analyses.
• Coordinate with external vendors and internal teams.
• Travel to customer sites domestically and internationally.

Skills

Cross-functional leadership

Systems engineering

Software development

Test & validation

Documentation

Education

Bachelor's degree in ME or EE

Job description

Field Medical is seeking a Sr. Systems Engineer in Carlsbad, CA to lead systems engineering across product development. You will guide DHF/DMR development, coordinate with R&D, quality, regulatory, and clinical teams, and ensure FDA compliance and international standards.

The role requires a hands-on leader who can plan technical specifications, develop test tools, track progress, and drive V&V activities across multiple disciplines. Domestic and international travel may be required.