Systems Engineer II

The Fountain Group; North Chicago (IL); Vor Ort; USD 133.000 - 144.000; Vollzeit

Zusammenfassung

The Fountain Group is seeking a Systems Engineer II to join their device development team in North Chicago, IL. You will lead use-related risk analyses and coordinate cross-functional activities across human factors, quality, clinical, and manufacturing.

You will drive DHF architecture, design controls, and risk management, ensuring robust documentation and regulatory alignment for clinical and commercial programs.

Qualifikationen

• BS in Engineering or closely related field with 5+ years in pharma/medical device settings.
• MS in Engineering with 3+ years preferred.
• Experience with FDA 21 CFR Part 820 and ISO 13485 is preferred.
• Strong written and verbal communication skills.
• Ability to multitask and meet timelines.

Aufgaben

• Lead URRA planning and coordination across programs.
• Facilitate cross-functional URRA meetings and ensure timely inputs from team members.
• Document hazards, use scenarios, risks, and mitigations with functional experts.
• Monitor milestones and proactively elevate risks or delays.
• Ensure URRA records are inspection-ready and compliant.

Kenntnisse

URRA leadership

Design Controls

DHF documentation

Cross-functional collaboration

Regulatory awareness

Ausbildung

BS in Engineering

MS in Engineering

Jobbeschreibung

The Fountain Group iscurrently seeking anSystems Engineer II for a prominent client of ours. This position is located in North Chicago, IL. Details for the position are as follows.

Title: Systems Engineer II (URRA)

Location: North Chicago, IL 60064, USA

Duration: 12+ months (Possible extension/conversion based on performance and budget)

Hourly Rate on W2: $64 - $69

Job Description

We areseeking 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.

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.

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