Senior Systems Engineer

Responsibilities

• Lead system design, integration, and software-centric product development for the EOS Insight Portal
• Drive concept development and system architecture for scalable cloud-based solutions
• Lead development of user needs, use cases, and system requirements with full traceability
• Own system-level risk management activities, including risk assessments and DFMEA
• Author technical inputs for FDA 510(k) submissions and other regulatory filings
• Drive verification and validation readiness through design documentation and test strategies
• Lead design control activities including phase reviews, DHF management, and change control

Requirements

• Strong understanding of distributed systems, web services, microservices, and REST APIs
• Proficiency in software development life cycle (SDLC), Agile methodologies, and DevOps
• Working knowledge of database systems, data models, and cloud-based data flow
• Expertise in architecture definition, requirements management, and risk analysis
• Experience with medical device product life cycles and design control processes
• BS Degree in Engineering (Software, Computer, Systems, Electrical, or Mechanical)
• Minimum 7+ years of engineering experience with at least 2 years in systems engineering
• Experience in regulated product development (medical device preferred)

Preferred Qualifications

• Advanced engineering degree
• Agile or Scrum certifications (e.g., Product Owner)
• INCOSE certified systems engineer