Lead Medical Device Systems Architect

Fortive; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Fortive in Irvine, CA seeks a Staff Systems Engineer to lead advanced systems development for complex medical devices. You will shape system architectures and translate requirements into actionable designs across mechanical, electrical, and software teams.

You will mentor engineers, coordinate with suppliers, and ensure design controls, verification, and regulatory alignment throughout concept to design transfer. Travel up to 20% is expected.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 10+ years of progressively responsible engineering experience in product and/or systems development.
• Experience with system-level design, integration, or verification.
• Knowledge of FDA, ISO, and QSR requirements.

Responsibilities

• Define, develop, and refine system architectures for new products and enhancements.
• Translate user, customer, and business needs into clear, testable system and subsystem requirements.
• Support lifecycle activities from concept through design transfer to manufacturing.
• Develop and maintain system-level documentation per design control processes.
• Provide technical guidance and mentorship across disciplines.
• Support testing, failure investigations, risk assessment, and validation activities.
• Interface with suppliers and external partners during design reviews and transfer readiness.

Skills

Systems engineering leadership

Cross-functional collaboration

Requirements management

Root cause analysis

Risk management

Technical documentation

Verbal and written communication

Travel up to 20%

Education

Bachelor's degree in Engineering or related

Tools

Design controls

FDA/Iso/QSR knowledge

Job description

Fortive in Irvine, CA seeks a Staff Systems Engineer to lead advanced systems development for complex medical devices. You will shape system architectures and translate requirements into actionable designs across mechanical, electrical, and software teams.

You will mentor engineers, coordinate with suppliers, and ensure design controls, verification, and regulatory alignment throughout concept to design transfer. Travel up to 20% is expected.