Senior 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

A fast growing Class II medical device company with established surgical products on the market and a pipeline of next generation connected devices in development. R&D is expanding to support multiple programs heading toward launch.

The Opportunity

This is the role for someone who sees the whole system and likes being the person who makes mechanical, electrical, and software work come together. When a mechanical change affects a board, or a software decision changes a test plan, you connect the dots, align the team, and keep the design documentation solid.

It’s a senior individual contributor role with real influence: you’ll be the technical thread across every program in R&D and help shape how these products come to market.

What You’ll Do

• 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

What You Bring

• BSEE, BSECE, or equivalent
• 5+ years of systems engineering in medical devices; an electrical engineering background is a plus
• A track record of aligning mechanical, electrical, and software engineers without direct authority
• Experience authoring requirements and traceable design documentation supporting FDA 510(k) submissions
• Strong working knowledge of V&V planning and execution, design FMEA, and risk management

Strong medical device systems experience and most of the above? Reach out anyway.

Why It Matters

As the pipeline grows, R&D needs one person keeping every discipline working from the same requirements. You’ll have a hand in every program you touch and see those products reach patients.