Senior Medical Systems Engineer – Regulatory & V&V Lead

Field Medical, Inc.; Carlsbad (CA); Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

Field Medical, Inc. in Carlsbad, CA is seeking a Sr. Systems Engineer to lead systems engineering across product development for next‑gen PFA devices. You will prepare DHF/DMR records, guide R&D projects, and drive V&V efforts with cross‑functional teams spanning engineering, quality, regulatory, and clinical.

The role requires a bachelor’s in engineering, 7+ years in medical devices, strong hardware/software experience, and ability to read schematics, use an oscilloscope and network analyzer.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or equivalent is required.
• 7+ years of engineering experience in medical devices with cross-functional leadership.
• 3+ years of systems engineering for multidisciplinary products with software and hardware.
• Must read schematics and use an oscilloscope and network analyzer to measure analog/digital signals.
• Electrical circuit analysis experience is required.
• Experience leading cross-functional alignment and driving execution without direct people management.
• Experience with development processes and technical documentation writing.
• Knowledge of software development and programming for tools and data analysis.

Responsabilités

• Write specifications for the system and sub-systems from customer needs.
• Define and document system architecture with SMEs.
• Verify design fit to system requirements with technical designers.
• Conduct and review analyses to validate simulations and design.
• Lead integration, V&V and verification activities across teams.
• Develop DHF and DMR records and keep notebooks up to date.
• Travel to customer sites for VOC, testing and troubleshooting.

Connaissances

Schematics reading

Oscilloscope

Network analyzer

Electrical circuit analysis

Cross-functional leadership

Software basics

Data analysis

Formation

Bachelor’s degree in Mechanical or Electrical Engineering

Outils

Programming for data analysis

Version control

Description du poste

Field Medical, Inc. in Carlsbad, CA is seeking a Sr. Systems Engineer to lead systems engineering across product development for next‑gen PFA devices. You will prepare DHF/DMR records, guide R&D projects, and drive V&V efforts with cross‑functional teams spanning engineering, quality, regulatory, and clinical.

The role requires a bachelor’s in engineering, 7+ years in medical devices, strong hardware/software experience, and ability to read schematics, use an oscilloscope and network analyzer.