R&D System Project Engineer (Combination Products/Medical Devices)

Location: North Chicago, IL 60064 Contract Period: 12 Months / 1 YearShift Timings: Mon - Fri, 08:00 AM - 05:00 PM CST

Location: This position is based in Lake County, IL. The role is part of a global team and requires regular collaboration with colleagues in France and the United State Contract: 1 year - based on performance and business needs Local candidates preferred here you guys as onsite for 2nd rounds is now a requirement. Please make sure they are able to make for onsite interview within a reasonable time (1 week or so)

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.

Systems Engineering Responsibilities: In support of the broader systems engineering framework, you will support the following activities and deliverables:

• System Architecture & Integration
• User and Stakeholder Needs Definition
• Use Case Analysis
• Standards Coverage Analysis
• Product Requirements Definition
• TraceabilityRisk Management planning and reporting
• System Risk Assessment
• Use-Related Risk Assessments, Design FMEAs, and Process FMEAsChange 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.