Design Engineer

Job Details:

Job Title: Project Engineer/ Systems Engineer/ Design Engineer

Location: Lake County, IL

Duration: 12 Months

Tax Term: W2

Notes from hiring manager:

Systems Engineering Group- Looking for system engineer facilitating Use related risk analysis for 50% of time and other systems engineering activities as needed for the other 50%

My pears are experienced systems engineers, so we are looking for someone who may not have as much experience- we are willing to mentor them and bring them up to sped.

Work with devices that are combination products as well as some aesthetics products –

Nice if person has some drug product manufacturing experience, but not required

Most of us are engineers with engineering background ( mechanical, chemical, biomechanical?

Position Snapshot

• Schedule: 100% onsite, open for relocation candidates
• Contract: Initially one year; extension depends on performance and business need
• Department: R&D – Device and Combination Product Development
• Interview process: Initial screening call followed by a video interview; onsite interview is not required
• Products: Primarily mechanical drug-delivery devices and combination products, with some aesthetics products

What the Manager Really Needs

The manager is seeking a systems engineer with medical-device development experience who already understands design controls and risk management.

Approximately half of the role will focus on use-related risk analysis. The engineer will examine how a patient or healthcare provider uses a device, identify possible use errors, and evaluate how those errors could result in harm.

The other half will involve broader systems-engineering activities, including design inputs, requirements, and risk documentation.

The manager is willing to mentor someone who is not highly senior, but does not want to teach the fundamentals of design controls.

Strongly Preferred Experience

Prioritize candidates with:

• Systems engineering experience or a Systems Engineer title
• Use-related risk analysis or usability/human-factors risk experience
• Experience evaluating:
• User workflows
• User tasks
• Foreseeable use errors
• Potential patient or end-user harm
• Mechanical drug-delivery device experience
• Design inputs, system requirements, and traceability experience
• Risk-management plans, risk assessments, FMEA, or similar documentation
• Combination-product or regulated medical-device R&D experience

Mechanical-device experience is preferred because it will help the candidate become productive faster, but it is not an absolute requirement.

The manager needs someone who understands design validation and device design controls.

Ideal Candidate Profile

The strongest candidate will likely be an early-to-mid-career systems, device-development, human-factors, or design engineer who has worked in a regulated medical-device or combination-product R&D environment.

They should be able to discuss specific examples of:

• Creating or updating use-related risk analyses
• Identifying user errors and connecting them to potential harm
• Developing design inputs or system requirements
• Producing risk-management documentation
• Working within a design-control process
• Representing engineering on a cross-functional project team

A strong submission should clearly show all four:

1. Medical-device or combination-product development
2. Design-controls experience
3. Device risk-management documentation
4. Confirmed ability to work 100% onsite

Use-related risk analysis and mechanical drug-delivery experience will distinguish the strongest candidates.

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.

AbbVie 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.

EEO

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”