R&D Systems Engineer - Medical Devices, Cross-Discipline

Caldera Medical, Inc.; Westlake Village (CA); Presencial; USD 110.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation assistance

Medical and Dental Benefits

Vision Coverage

401(k) with 4% matching

Basic Life and AD&D

Unlimited Vacation Policy

6 Weeks Paid Maternity Leave

10 paid holidays

Collaborative culture

Descripción de la vacante

Caldera Medical in Westlake Village, CA, is seeking a Systems Engineer to act as the technical thread across our R&D programs, uniting mechanical, electrical, and software work to deliver integrated medical devices.

In this individual contributor role, you will connect dots between disciplines, maintain solid design documentation, and influence multiple programs toward successful launches while ensuring FDA 510(k) readiness.

Formación

• BSEE, BSECE, or equivalent required.
• 5–7 years of medical device systems engineering experience.
• Experience aligning mechanical, electrical, and software engineers without direct authority.
• Experience authoring requirements, design inputs/outputs, and FDA 510(k) documentation.
• Knowledge of V&V planning and risk management.

Responsabilidades

• Connect mechanical, electrical, and software work across programs with aligned, documented decisions.
• Author and maintain requirements, design inputs/outputs with traceability for FDA 510(k).
• Apply board- and component-level understanding to fit electrical and mechanical pieces.
• Collaborate with Electrical, Mechanical, and firmware/software teams to move programs to launch.
• Ensure verification and validation plans are thorough across disciplines.
• Support design FMEAs and risk management with Quality.
• Prioritize across a varied project portfolio to focus effort where it matters most.

Conocimientos

Systems engineering

FDA 510(k) experience

Requirements tracing

Cross-functional collaboration

V&V planning

Risk management

Educación

BSEE / BSECE or equivalent

Descripción del empleo

Caldera Medical in Westlake Village, CA, is seeking a Systems Engineer to act as the technical thread across our R&D programs, uniting mechanical, electrical, and software work to deliver integrated medical devices.

In this individual contributor role, you will connect dots between disciplines, maintain solid design documentation, and influence multiple programs toward successful launches while ensuring FDA 510(k) readiness.