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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Program Engineer - **Company:** SYNECTICS INC - **Location:** North Chicago, IL, United States - **Experience:** Expert - **Salary:** $114,941.0 - $143,666.0 - **Contract:** Permanent contract - **Skills:** Systems Engineering, Configuration Management, Document Management Systems, Failure Mode Effects Analysis, Systems Development Life Cycle, Software Requirements Analysis, Systems Architecture - **Published:** August 6, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=e7986df3759d9999 ## About the Role * BS in Engineering, Science, or a closely related discipline with 10+ years of relevant experience; or MS with 8+ years of experience. * 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. * 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. ## Description * 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 ## 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) - [Navigating the Corporate Jungle: Life as a Developer in a large Company](https://www.wearedevelopers.com/videos/621-navigating-the-corporate-jungle-life-as-a-developer-in-a-large-company) - [The QUEST for Better Software](https://www.wearedevelopers.com/videos/721-the-quest-for-better-software) - [Terraform for Developers](https://www.wearedevelopers.com/videos/3-terraform-for-developers) - [Why Your Best Mediors Never Become Seniors (And How to Fix It)](https://www.wearedevelopers.com/videos/2108-why-your-best-mediors-never-become-seniors-and-how-to-fix-it) - [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) ## 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) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [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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