R&D System Project Engineer

JobDiva, Inc.; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

JobDiva, Inc. is seeking a Systems Engineer focused on Use-Related Risk Analysis (URRA) for drug products and delivery systems.

You will coordinate URRA activities, integrate inputs from human factors, quality, clinical, medical safety, development, and manufacturing, and drive risk-based design decisions to ensure patient-centered products. You will partner with a global team to ensure compliance with internal procedures and regulatory requirements, including design controls, QbD, and risk

Qualifications

• Experience in pharmaceutical/medical device development (5+ years).
• Familiarity with FDA 21 CFR Part 820.30 and ISO 14971.
• Ability to lead URRA activities across programs.
• Proven ability to coordinate cross-functional teams.
• Experience with Design Control and DHF management.
• Strong analytical, writing and verbal communication skills.
• Experience with vendor management and external partners.
• Multitask and meet tight timelines.

Responsibilities

• Lead planning and coordination of URRA activities across programs.
• Facilitate cross-functional meetings to develop URRA analyses.
• Document hazards, use scenarios, failure modes, risks, and mitigations.
• Monitor milestones and escalate risks or issues early.
• Support URRA documentation to ensure inspection readiness.
• Drive consistency and identify process improvements in URRA.
• Support system architecture, requirements, traceability, and risk management.
• Coordinate change management and third-party development integration.

Skills

URRA leadership

Risk management

Systems engineering

Regulatory alignment

Cross-functional coordination

Documentation planning

Project planning

Vendor management

Education

BS in Engineering

MS in Engineering (optional)

Job description

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.

Roles and Responsibilities:

• 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 escal 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.
• 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
• 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

Experience:

• 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.

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.
• 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.