URRA-Focused Project Engineer, Combination Products

Wall Street Consulting Services LLC; North Chicago (IL); On-site; USD 95,000 - 130,000; Full time

Job summary

Wall Street Consulting Services LLC is seeking a Systems Engineer to join the Device and Combination Product Development team within R&D. This role focuses on use-related risk analysis and design controls across drug-device delivery systems.

Based in North Chicago, IL, the position requires on-site work, collaboration with global teams, and 3–5 years in medical devices or regulated environments, with an emphasis on URRA, DHF, and cross-functional integration.

Qualifications

• Experience in combination product or medical device development.
• Familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485.
• End-to-end product development experience.
• Proficiency in DHF management and Design Control documentation.
• Strong organizational and communication skills.

Responsibilities

• Lead planning and coordination of use-related risk analyses (URRA) across programs.
• Coordinate cross-functional meetings to develop URRA documentation and mitigations.
• Support Design Controls, risk management, traceability, and DHF architecture.
• Collaborate with human factors, quality, regulatory, and manufacturing teams.
• Interface with vendors and drive timely risk-based decision making.

Skills

Use-Related Risk Analysis

Human Factors Engineering

Risk Management

Design Control & DHF

Cross-functional Collaboration

Regulated Environments

Education

BS in Engineering/Science

MS in Engineering/Science (optional)

Job description

Wall Street Consulting Services LLC is seeking a Systems Engineer to join the Device and Combination Product Development team within R&D. This role focuses on use-related risk analysis and design controls across drug-device delivery systems.

Based in North Chicago, IL, the position requires on-site work, collaboration with global teams, and 3–5 years in medical devices or regulated environments, with an emphasis on URRA, DHF, and cross-functional integration.