Project Engineer II

Title: Project Engineer II

Duration: 12 months with possible extension

Location/Site: North Chicago, IL - 60064 (Onsite)

Description

Top 3-5 Skills:

1. Working knowledge of use-related risk analysis, human factors, risk management, or product development preferred

2. 3-5 years of experience in pharmaceutical, medical device, combination product, or other regulated industry environments.

3. Expertise in DHF management and creating various Design Control documents in compliance with applicable regulations.

4. Strong organizational, facilitation, and communication skills.

5. Familiarity with relevant human factors and risk management expectations.

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.