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

Wall Street Consulting Services LLC

North Chicago, IL 60086, USA

Published: 6/14/2022

Technology

Full Time

Job Description

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

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.

Ability to multitask effectively and deliver results within established timelines.