Project Engineer II

Stellent IT LLC; North Chicago (IL); On-site; USD 85,000 - 110,000; Full time

Job summary

Stellent IT LLC is seeking a Systems Engineer focused on Use-Related Risk Analysis (URRA) to drive risk analyses for device and combination product development. You’ll coordinate cross-functional teams across human factors, quality, clinical, medical safety, development, and manufacturing to deliver inspection-ready URRA docs and robust risk mitigations.

You will integrate inputs to ensure patient-centric design,維 with regulatory and quality standards, supporting both clinical and commercial

Qualifications

• Experience in end-to-end product development, incl. medical device or combination products.
• Familiarity with FDA 21 CFR Part 820.30, ISO 14971, ISO 13485, EU MDR preferred.
• Strong written and verbal communication skills; scientific writing ability.
• Ability to multitask and deliver on timelines.

Responsibilities

• Lead URRA planning across programs and coordinate cross-functional activities.
• Document hazards, use scenarios, risks, and mitigations with stakeholders.
• Collaborate with human factors, quality, clinical, medical safety, development, and manufacturing teams.
• Ensure DHF architecture and Design Controls alignment across programs.
• Define system requirements, traceability, and risk management plans.
• Oversee change management and integration of third-party development.

Skills

URRA

System Architecture

Risk Management

Traceability

Vendor Liaison

Education

BS in Engineering/Science

MS with 3+ years

Tools

Project Tracking Tools

Document Management

Job description

Title: Project Engineer II Duration: 12 Months Location: North Chicago, IL - Local

Client is seeking a Systems Engineer to join their Device and Combination Product Development team within R&D. This individual will contribute to the development of innovative devices and therapeutic combination products across various phases of clinical studies and will work closely with cross-functional colleagues in operations as programs transition to commercial development.

Position Summary

As a Systems Engineer with a primary focus on Use-Related Risk Analysis (URRA), you will be responsible for coordinating and driving the successful completion of use-related risk analyses for drug products and associated delivery systems - including on-body devices, pre-filled syringes, autoinjectors, mixing devices, and complex electromechanical pumps. You will integrate inputs and risks from multiple disciplines to ensure robust, patient-centric product design and performance, while partnering closely with cross-functional stakeholders across human factors, quality, clinical, medical safety, development, and manufacturing teams. Working alongside a global team of scientists, engineers, and leaders, your expertise and leadership will ensure that all systems are safe, effective, and aligned with applicable internal procedures, regulatory expectations, and quality standards - for both clinical and commercial development programs.

Core Responsibilities

You will be responsible for implementing holistic systems engineering principles within the Design Controls process, with a PRIMARY focus on Use-Related Risk Analysis (URRA) and additional focus on Design Inputs, Risk Management, Traceability, Systems Integration, and DHF architecture.

PRIMARY RESPONSIBILITY: Use-Related Risk Analysis (URRA)

• Lead planning and coordination of creating use-related risk analysis activities across all assigned programs.
• Facilitate cross-functional meetings to drive development of use-related risk analyses, ensuring team members provide timely inputs for which they are responsible.
• Partner with functional experts - including human factors, quality, clinical, medical safety, development, and manufacturing - to support accurate documentation of hazards, use scenarios, failure modes (i.e., use errors), risks, and mitigations.
• Monitor progress against milestones and proactively escalate risks, delays, and unresolved issues to appropriate stakeholders.
• Support team development and review of URRA documentation to ensure delivery of inspection-ready records to the URRA owner.
• Drive consistency in URRA process execution and continuously identify opportunities for process improvement.

Systems Engineering Responsibilities

• System Architecture & Integration
• User and Stakeholder Needs Definition
• Use Case Analysis
• Standards Coverage Analysis
• Product Requirements Definition
• Traceability
• Risk Management planning and reporting
• System Risk Assessment
• Use-Related Risk Assessments, Design FMEAs, and Process FMEAs
• Change Management
• Oversight and integration of Third-Party Development activities
• Integration of Design Control and Quality by Design (QbD) activities

Qualifications

• Demonstrated ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
• Expertise in end-to-end product development from initial concept through market release, with direct experience in combination product or medical device development; familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR preferred.
• Expertise in Systems Engineering principles including user and stakeholder need definition, requirements definition, risk management, product architecture, configuration management, traceability, and change management.
• Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
• Working knowledge of use-related risk analysis, human factors, and risk management methodologies.
• Strong organizational, facilitation, and communication skills with the ability to influence across a matrixed organization and manage competing priorities.
• Strong analytical and decision-making skills; self-driven and proactive in approach.
• Experience creating and managing project schedules and identifying project risks and mitigation plans.
• Proficiency with project tracking and document management tools.
• Experience interfacing with third-party vendors, including communication management, deliverable acceptance testing, and multi-cultural awareness.

Preferred Experience

• Experience supporting drug product and delivery system development.
• Familiarity with relevant human factors and risk management regulatory expectations.
• Ability to synthesize complex technical input into clear, actionable plans and documentation.
• Demonstrated proactive, collaborative approach in a fast-paced, highly matrixed environment.
• Experience in vendor communication, management, and deliverable acceptance testing.

Education & Experience

• BS in Engineering, Science, or a closely related discipline with 5+ years of relevant experience; or MS with 3+ years of experience.
• 3-5 years of experience specifically in pharmaceutical, medical device, combination product, or other regulated industry environments preferred.
• Demonstrated scientific writing skills and strong verbal communication skills.
• Ability to multitask effectively and deliver results within established timelines.