Senior Medical Device Systems Engineer (FDA-Driven)

Titan, Inc; San Diego (CA); Hybrid; USD 150,000 - 185,000; Full time

Job summary

Titan, Inc. seeks a Senior Systems Engineer for medical devices and IVD instruments in an on-site San Diego role. You will own system integration, requirements management, and design verification to deliver compliant, manufacturable products across complex platforms.

You'll partner with FDA submission teams, lead cross-functional design reviews, and mentor engineers to ensure robust architecture and risk controls throughout the product lifecycle.

Qualifications

• 8+ years of systems engineering experience in IVD or human-use medical devices.
• Hands-on FDA 510(k) and De Novo submissions experience.
• Deep knowledge of design controls (21 CFR 820.30, ISO 13485) and ISO 14971.

Responsibilities

• Define and maintain system architecture across fluidic, chemical, mechanical, electrical and software subsystems.
• Own system-level requirements flow-down and bidirectional traceability.
• Lead system-level design reviews, interface control, and risk analyses (ISO 14971).
• Mentor engineers across disciplines on systems engineering and verification planning.

Skills

Systems engineering

Requirements management

Design verification

Cross-functional leadership

Education

Bachelor's degree in Systems, Biomedical, Electrical, or Mechanical Engineering

MS or PhD preferred

Tools

Requirements management tools

V&V planning/execution

Job description

Titan, Inc. seeks a Senior Systems Engineer for medical devices and IVD instruments in an on-site San Diego role. You will own system integration, requirements management, and design verification to deliver compliant, manufacturable products across complex platforms.

You'll partner with FDA submission teams, lead cross-functional design reviews, and mentor engineers to ensure robust architecture and risk controls throughout the product lifecycle.