Staff Systems Engineer – Medical Devices, Lead & Equity

Advanced Sterilization Products; Irvine (CA); On-site; USD 158,000 - 263,000; Full time

Job summary

Advanced Sterilization Products, a Fortive company, seeks a Staff Systems Engineer to lead system-level design for complex medical devices from concept through transfer to manufacturing. You will translate customer and regulatory requirements into executable designs and guide cross-functional teams.

The role emphasizes collaboration, risk management, and maintaining rigorous design controls while mentoring engineers and coordinating with suppliers and test labs.

Qualifications

• 10+ years of progressively responsible engineering experience in product and/or systems development.
• Experience with system-level design, integration, or verification activities.
• Working knowledge of FDA, ISO, and QSR requirements applicable to medical device development and design controls.
• Proficiency in root cause investigation, risk management, change management, and technical documentation.

Responsibilities

• Contribute to the definition, development, and refinement of system architectures for new products and significant product enhancements.
• Translate user, customer, and business needs into clear, testable system and subsystem requirements.
• Support system development activities across the product lifecycle, including concept development, requirements definition, design, verification and validation, and design transfer to manufacturing.
• Develop and maintain system-level documentation, including development plans, architectures, requirements, traceability matrices, specifications, test plans, and reports.
• Provide technical guidance and informal mentorship to engineers and technicians across disciplines.

Skills

Systems engineering

Requirements management

Verification & validation

Design controls

Cross-functional collaboration

Root cause analysis

Education

Bachelor’s degree in Engineering

Job description

Advanced Sterilization Products, a Fortive company, seeks a Staff Systems Engineer to lead system-level design for complex medical devices from concept through transfer to manufacturing. You will translate customer and regulatory requirements into executable designs and guide cross-functional teams.

The role emphasizes collaboration, risk management, and maintaining rigorous design controls while mentoring engineers and coordinating with suppliers and test labs.