System Engineer

Role Overview

The Systems Engineer will act as the technical integrator across Mechanical, Electrical, Software, Hardware, Product Management, Quality and Regulatory functions, translating user needs into system requirements, architecture, interfaces, risk controls and verification/validation activities.

Key Responsibilities

• Capture and analyze user needs and product requirements. 
• Develop System Requirements Specifications. 
• Decompose system requirements into subsystem requirements. 
• Establish and maintain requirements traceability.
• Define system architecture and subsystem interfaces.
• Coordinate Mechanical, Electrical, Software and other engineering disciplines.
• Support HW/SW/Mechanical integration.
• Lead or participate in system design reviews.
• Develop system-level specifications.
• Perform system-level risk assessments.
• Support Hazard Analysis, FMEA and Risk Management.
• Define risk controls and verify their implementation.
• Develop system V&V strategies.
• Develop verification protocols and reports.
• Support design validation activities.
• Analyze system-level failures and integration issues.
• Drive cross-functional technical problem resolution.
• Support product cybersecurity / security-by-design activities where applicable.
• Support design transfer and manufacturability/testability.
• Support DHF and regulatory documentation.
• Support regulatory submissions.
• Manage requirements and technical changes.
• Coordinate with external engineering/development partners.
• Support product commercialization.