Senior Medical Device Systems Architect

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

Job summary

Advanced Sterilization Products, Inc. is seeking a Staff Systems Engineer to provide advanced technical leadership for medical device system development from concept through design transfer.

You will help define architecture, translate requirements, and guide cross-functional teams across mechanical, electrical, and software domains. The role demands a strong background in system-level design, verification and validation, and regulatory controls (FDA/ISO/QSR).

Qualifications

• Bachelor's degree in Engineering or related technical discipline; equivalent combination of education and experience.
• Minimum 10+ years of progressively responsible engineering experience in product and/or systems development, including exposure to system-level design, integration, or verification activities.

Responsibilities

• Contribute to the definition, development, and refinement of system architectures for new products and significant product enhancements, ensuring alignment with customer needs, regulatory requirements, and business objectives.
• Translate user, customer, and business needs into clear, testable system and subsystem requirements, and support effective flow-down of requirements to mechanical, electrical, and software teams.
• Support and execute system development activities across the product lifecycle, including concept development, requirements definition, design, verification and validation, and design transfer to manufacturing.
• Develop, review, and maintain system-level documentation, including development plans, architectures, requirements, traceability matrices, specifications, test plans, protocols, reports, and technical analyses, in accordance with design control processes.
• Provide technical guidance and informal mentorship to engineers and technicians, coordinating across disciplines and contributing to technical direction under the guidance of senior technical or project leadership.
• Support system-level testing, failure investigations, and technical assessments, evaluating reliability, manufacturability, serviceability, and risk throughout development
• Act as a technical contributor and interface to suppliers, external partners, and test laboratories, supporting design reviews, testing execution, issue resolution, and design transfer readiness.

Skills

System architecture

Regulatory knowledge

Root cause analysis

Risk management

Design controls

Cross-functional collaboration

Project management

Travel readiness

Education

Bachelor’s degree in Engineering

Job description

Advanced Sterilization Products, Inc. is seeking a Staff Systems Engineer to provide advanced technical leadership for medical device system development from concept through design transfer.

You will help define architecture, translate requirements, and guide cross-functional teams across mechanical, electrical, and software domains. The role demands a strong background in system-level design, verification and validation, and regulatory controls (FDA/ISO/QSR).