Project Engineer

Stark Pharma Solutions Inc; Great Lakes (IL); On-site; USD 120,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc. in Illinois seeks an experienced Project Engineer to lead URRA, DHF, Design Control and Systems Engineering for medical device programs.

You will collaborate with Quality, Clinical, Manufacturing and Engineering to ensure regulatory compliance and robust risk management across lifecycle.

This long-term role requires hands-on leadership, strong analytical skills, and the ability to drive risk mitigation in a regulated environment.

Qualifications

• BS or MS in Engineering or related discipline with 8+ years of relevant experience.
• Experience in regulated industries (pharma/medical devices) with 5+ years in development or QA/Regulatory roles.
• Expertise in Design History File (DHF) management and Design Control documentation.
• Strong understanding of systems engineering, 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 and cross-functional collaboration skills.

Responsibilities

• Lead URRA activities across multiple projects.
• Facilitate cross-functional meetings to develop risk management documentation.
• Collaborate with Human Factors, Quality, Clinical, Manufacturing and Engineering teams on hazards, risks and mitigations.
• Develop and maintain DHF and Design Control documentation.
• Support Systems Engineering activities including requirements management, traceability and risk assessments.
• Perform and review Use-Related Risk Assessments, D-FMEA and P-FMEA.
• Track project schedules, milestones, risks and deliverables; communicate status to stakeholders.
• Support change management, vendor coordination, and QbD activities.
• Ensure compliance with FDA regulations, ISO standards and medical device quality requirements.

Skills

Systems engineering

Requirements management

Traceability

Cross-functional collaboration

Documentation leadership

Education

BS in Engineering or related discipline

MS in Engineering or related discipline

Job description

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.

Position: Project Engineer

Location: Illinois

Duration: Long Term

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.