> Markdown version of [/jobs/ext/2288944-project-systems-engineer](https://www.wearedevelopers.com/jobs/ext/2288944-project-systems-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Project Systems Engineer - **Company:** Intellectt, Inc - **Location:** North Chicago, IL, United States - **Experience:** Expert - **Salary:** $120,000.0 - $150,000.0 - **Contract:** Temporary to permanent - **Skills:** Systems Engineering, Configuration Management, Failure Mode Effects Analysis, Software Requirements Analysis, Systems Architecture, Systems Integration - **Published:** August 29, 2026 - **Apply:** https://www.careerjet.com/jobad/us1a64503fea843d284d0933cee8ed04f2 ## About the Role The ideal candidate will have 3 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industries, with strong knowledge of human factors, risk management, FDA regulations, and Design Control processes., * 3 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated environments. * Hands-on experience with URRA / Use-Related Risk Analysis. * Strong DHF and Design Control experience. * Knowledge of Systems Engineering and product development lifecycle. * Experience with requirements definition, traceability, risk management, and change management. * Working knowledge of Human Factors and use-related risk management. * Strong cross-functional facilitation, communication, and stakeholder management skills. * Experience managing project schedules, risks, milestones, and deliverables. Regulatory / Technical Knowledge * FDA 21 CFR Part 820.30 * 21 CFR Part 4 * ISO 14971 * ISO 13485 * EU MDR * Design Controls * Risk Management * Human Factors * DHF Management * Design Verification / Validation * FMEA * Requirements & Traceability Preferred * Experience with drug-delivery systems or combination products. * Experience with autoinjectors, pre-filled syringes, on-body delivery devices, mixing devices, or electromechanical pumps. * Vendor/third-party development experience. * Experience working in global, highly matrixed R&D organizations. * Strong technical/scientific writing and documentation skills. ## Description Seeking a Project Engineer II / Systems Engineer to support the development of pharmaceutical delivery devices and combination products within a regulated R&D environment. The role will primarily focus on Use-Related Risk Analysis (URRA), Design Controls, DHF management, risk management, requirements, traceability, and systems integration across clinical and commercial development programs., * Lead and coordinate Use-Related Risk Analysis (URRA) activities across assigned programs. * Facilitate cross-functional reviews involving Human Factors, Quality, Clinical, Medical Safety, Engineering, Manufacturing, and Development teams. * Identify and document hazards, use scenarios, use errors, failure modes, risks, and mitigations. * Manage and maintain Design History File (DHF) documentation and Design Control deliverables. * Support user needs, stakeholder requirements, product requirements, system architecture, and traceability activities. * Develop and support risk management plans, system risk assessments, URRA, DFMEA, and PFMEA activities. * Ensure compliance with applicable FDA and international regulatory requirements. * Track project milestones, risks, issues, dependencies, and mitigation actions. * Support change management, configuration management, systems integration, and third-party development activities. * Collaborate with vendors on deliverables, technical reviews, acceptance testing, and project execution. * Ensure project documentation is complete, consistent, audit-ready, and inspection-ready., Job Description We are seeking an HVAC Mechanical Engineer / Project Developer to join our federal team that specializes in supporting U.S. military and other U.S. federal govern… + 13 days ago + ## Related Videos - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [AI Agents & Agentic AI](https://www.wearedevelopers.com/videos/2017-ai-agents-agentic-ai) - [The QUEST for Better Software](https://www.wearedevelopers.com/videos/721-the-quest-for-better-software) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Breaking the Hardware Mindset: Overcoming Barriers to System-Level Innovation](https://www.wearedevelopers.com/videos/1635-breaking-the-hardware-mindset-overcoming-barriers-to-system-level-innovation) - [UX is a fullstack job!](https://www.wearedevelopers.com/videos/1020-ux-is-a-fullstack-job) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Events like RSAC Get You CISOs. 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