Project Engineer

Position: Project Engineer
Location: Illinois
Duration: Long Term

Job Overview

We are seeking an experienced Project Engineer to support medical device and combination product development projects. The ideal candidate will lead Use-Related Risk Analysis (URRA), Systems Engineering, and Design Control activities while collaborating with cross-functional teams to ensure successful product development and regulatory compliance.

Key Responsibilities

• Lead and coordinate Use-Related Risk Analysis (URRA) activities across multiple projects.
• Facilitate cross-functional meetings to develop and maintain risk management documentation.
• Collaborate with Human Factors, Quality, Clinical, Manufacturing, and Engineering teams to identify hazards, risks, and mitigation strategies.
• Develop and maintain Design History Files (DHF) and Design Control documentation.
• Support Systems Engineering activities, including requirements management, traceability, system architecture, and risk assessments.
• Perform and review Use-Related Risk Assessments, Design FMEAs, and Process FMEAs.
• Monitor project schedules, milestones, risks, and deliverables while communicating project status to stakeholders.
• Support change management, third-party vendor coordination, and Quality by Design (QbD) activities.
• Ensure compliance with FDA regulations, ISO standards, and medical device quality requirements.

Required Qualifications

• BS in Engineering, Science, or a related discipline with 10+ years of experience, or MS with 8+ years of relevant experience.
• 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industries.
• Expertise in Design History File (DHF) management and Design Control documentation.
• Strong knowledge of Systems Engineering, product development, requirements management, and traceability.
• Experience with Use-Related Risk Analysis (URRA), Human Factors Engineering, Risk Management, Design FMEA, and Process FMEA.
• Familiarity with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR.
• Experience with project scheduling, document management tools, and vendor management.
• Excellent analytical, organizational, communication, and cross-functional collaboration skills.