Senior Medical Device Systems Engineer

Precision Point; Los Angeles (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Precision Point is seeking a Senior Systems Engineer to lead cross-disciplinary integration of mechanical, electrical, and software work across multiple medical device programs. You will ensure traceable requirements and rigorous documentation as products move toward FDA submissions.

The role emphasizes influencing design decisions across teams, owning V&V planning and risk management, and guiding programs toward successful launches with a strong technical thread through R&D.

Qualifications

• 5+ years of systems engineering in medical devices.
• Experience authoring requirements and traceable design documentation for FDA 510(k).
• Strong knowledge of V&V planning and execution, design FMEA, and risk management.

Responsibilities

• Lead systems engineering across multiple active programs, keeping mechanical, electrical, and software design decisions aligned and documented.
• Own requirements, design inputs, and design outputs with full traceability through FDA 510(k) submission.
• Apply board and component level understanding to how electrical and mechanical subsystems fit together.
• Partner with electrical, mechanical, and firmware/software teams to drive programs through design freeze and launch.
• Own the accuracy and completeness of V&V plans across disciplines.
• Drive design FMEAs and risk management in partnership with Quality.
• Prioritize across a varied portfolio, putting effort where it matters most.

Skills

Systems engineering

Medical devices

Requirements tracing

V&V planning

Risk management

Education

BSEE / BSECE or equivalent

Tools

Design FMEA

Traceability

Job description

Precision Point is seeking a Senior Systems Engineer to lead cross-disciplinary integration of mechanical, electrical, and software work across multiple medical device programs. You will ensure traceable requirements and rigorous documentation as products move toward FDA submissions.

The role emphasizes influencing design decisions across teams, owning V&V planning and risk management, and guiding programs toward successful launches with a strong technical thread through R&D.