Senior Staff Engineer, Systems - San Diego

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Position Summary

Thesenior staff Systems Engineer works withthe development team by applying an interdisciplinary approach to the successful definition, development, integration, and testing of complex in vitro diagnostic systems.They will document user requirements, develop system requirements, participate in product architecture and design, drive risk analysis, and support integration and testing for new product introductions .

Position Summary

Thesenior staff Systems Engineer works withthe development team by applying an interdisciplinary approach to the successful definition, development, integration, and testing of complex in vitro diagnostic systems.They will document user requirements, develop system requirements, participate in product architecture and design, drive risk analysis, and support integration and testing for new product introductions .

Responsibilities

Key Accountabilities

Essential Functions

• Provide technical leadership to project teams.
• Responsible for the development of the system requirements documentation and overall requirements management.
• Applies architectural & design skills to work with senior development engineers to decompose the System Requirements into a structured hierarchy of sub-systems and interfaces . Creates system architecture document ation .
• Participates in development activities, such as performing hazard and risk analysis, assisting with requirements and design, and attending design reviews, etc.
• Works with product management and marketing to define user needs.
• Drives system integration, optimization, and root cause analysis with the development team during system integration, Alpha testing, and device pre-Beta testing.
• Uses statistical methods such as Design for Six Sigma ( DfSS ) and Design of Experiments ( D o E ) to increase product robustness and reliability .
• Leads risk management activities (e.g., Design Risk Analysis ) in accordance with ISO14971 .
• Ensures compliance with design‑control regulations (21CFR820.30), ISO13485, and IVDR throughout the product lifecycle .
• Works with the testing team to develop strategies for system level product integration and testing, including software, electrical, analytic, and mechanical aspects of the system.
• Supports the clinical team as needed to ensure a structured approach to product validation.
• Creates work breakdown structures as needed.
• May create verification reports and overall verification summary .
• Demonstrates excellent written and verbal communication skills.

Qualifications

Minimum Knowledge & Experience Required :

Skills

Skills & Capabilities :

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Engineering and Information Technology

Industries

Medical Equipment Manufacturing

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