Project Engineer II

Systems Engineer

Lake County - 100% Onsite Required Contract: 1 year - based on performance and business needs Top 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.

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.

Core Responsibilities: 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. 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: 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.

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