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

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

Location: North Chicago, IL 60064

Contract Period: 12 Months / 1 Year

Shift Timings: Mon - Fri, 08:00 AM - 05:00 PM CST

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

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 Overview

• We are seeking a Project Engineer to join the Systems Engineering team within R&D (Device & Combination Products Development). This role primarily supports use-related risk analysis (Human Factors & Risk Management) and contributes to broader systems engineering activities.
• This is a highly collaborative, cross-functional role where the engineer will represent systems engineering in product development teams, focusing on patient safety, user interaction, and design control compliance.

Manager's Update

• Perform use-related risk analysis (URRA) by evaluating user workflows, identifying potential user errors, and assessing patient risk
• Develop and maintain risk management documentation aligned with regulatory standards
• Create and manage Design Control documents within the Design History File (DHF)
• Collaborate with cross-functional teams (R&D, design, quality, regulatory)
• Represent systems engineering in product development discussions
• Facilitate discussions on best practices, risk alignment, and design improvements
• Support development of combination products (drug-device systems)
• 3–5 years of experience in Medical Devices, Pharmaceutical / Biotech, Combination Products or Other regulated industries
• Hands-on experience with Risk analysis (FMEA, URRA, etc.)
• Experience with Design validation vs. process validation (clear understanding required)
• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Or related engineering field
• Systems Engineer in Medical Devices or Combination Products
• Product Development Engineer with design control + risk management exposure
• Experience working on drug delivery devices or patient-use products
• Experience with API / drug formulation
• 8 to 10 years of experince can be overqualified
• Relocation candidates will work (but want strong reason)

Must-Have Skills (Non-Negotiable)

• Use-Related Risk Analysis / Human Factors Engineering
• Risk Management Knowledge (ISO standards, patient safety focus)
• Design Control & DHF Documentation Experience
• Strong communication and cross-functional collaboration skills
• Experience in regulated environments (medical device, pharma, or combination products)

Preferred Skills (Good to Have)

• Background in mechanical or drug delivery devices
• Experience with combination products (device + drug)
• Exposure to human factors engineering standards
• Knowledge of product development lifecycle in R&D
• Familiarity with global regulatory standards (FDA, ISO 14971, IEC 62366)

Top 3-5 Skills:

• Working knowledge of use-related risk analysis, human factors, risk management, or product development preferred
• 3-5 years of experience in pharmaceutical, medical device, combination product, or other regulated industry environments.
• Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.
• Strong organizational, facilitation, and communication skills.
• Familiarity with relevant human factors and risk management expectations.

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

• 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

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. xhyhwjd
• Ability to multitask effectively and deliver results within established timelines.