Position Summary:

The senior staff Systems Engineer works with the 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.  

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 documentation. 
  • 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 (DoE) to increase product robustness and reliability. 
  • Leads risk management activities (e.g., Design Risk Analysis) in accordance with ISO 14971. 
  • Ensures compliance with design‑control regulations (21 CFR 820.30), ISO 13485, 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.   

Minimum Knowledge & Experience Required: 

• BS/BA degree in CS, CE, EE, Biomedical or related engineering discipline required; MS/ME degree preferred. 
• 10+ years industry experience.  
• Experience in the full development lifecycle with at least one product required.  
• Experience in Medical device development or other Regulated industry required.  
• Experience with FDA Class II or III medical devices, including submission support (510(k) or PMA) preferred. 
• Proven familiarity with ISO 13485 quality management systems and design control best practices. 

Skills & Capabilities: 

• Experience applying DOE to systems under development.   
• Experience in the application of Human Factors is desired.  
• Experience leading system verification activities.  
• Experience in testing analog and digital/real-time embedded devices.   
• Good communication and presentation skills.  
• Good team player and leader.  
• Comprehensive knowledge of 21 CFR Part 820 and ISO 14971 risk management processes. 
• Proficiency with requirements management tools (e.g., Jama, DOORS).