Systems Engineer - Use-Related Risk Analysis

Spectraforce Technologies; North Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies is seeking a Project Engineer II to lead use-related risk analyses (URRA) and drive systems engineering activities for drug delivery and combination products. The role spans cross-functional collaboration with human factors, quality, clinical, and manufacturing to ensure safe, effective devices through development and into commercialization.

Focus areas include URRA coordination, risk management, design controls, DHF documentation, and cross-team integration to maintain

Qualifications

• Experience in combination product or medical device development with familiarity with FDA and ISO standards.
• End-to-end product development experience from concept to market release.
• Strong Systems Engineering credentials including requirements, architecture, traceability, and change management.
• Experience in Design History File (DHF) management and creation of Design Control documents.
• Knowledge of use-related risk analysis, human factors, and risk management methodologies.

Responsibilities

• Lead URRA planning and cross-functional coordination across programs.
• Collaborate with human factors, quality, clinical, medical safety, development, and manufacturing teams.
• Support URRA documentation to ensure inspection-ready records for URRA owners.
• Drive URRA process consistency and identify opportunities for improvement.
• Oversee system architecture, needs definition, traceability, and risk reporting.

Skills

Systems Engineering

Risk Management

Documentation

Vendor Management

Project Scheduling

Education

BS in Engineering or related

MS in Engineering or related

Job description

Spectraforce Technologies is seeking a Project Engineer II to lead use-related risk analyses (URRA) and drive systems engineering activities for drug delivery and combination products. The role spans cross-functional collaboration with human factors, quality, clinical, and manufacturing to ensure safe, effective devices through development and into commercialization.

Focus areas include URRA coordination, risk management, design controls, DHF documentation, and cross-team integration to maintain