Systems Engineer

Headquartered in Itasca, Illinois, with a satellite location in Belgium, Organ Recovery Systems is a global market-leading provider of organ preservation products and services. We support over 400 transplant programs across 49 countries. In 2025, the company reached 275,000 kidneys perfused with LKT since its launch in 2003. Life Port Kidney Transporter is among a growing family of products and services developed by Organ Recovery Systems to support the Company’s mission of honoring organ donation by delivering innovative solutions that support transplant professionals and improve long-term outcomes for patients.

The Staff Systems Engineer is a senior individual contributor and technical leader responsible for strengthening the definition, integration, traceability, verification, and controlled evolution of ORS products and platforms. The role translates stakeholder, clinical, business, regulatory, and product needs into coherent system requirements, interfaces, acceptance logic, risk-control relationships, and evidence strategies. The position leads major systems-engineering work streams across new-product development, modernization, sustaining engineering, investigations, and regulatory remediation.

The Staff Systems Engineer is an ORS subject-matter leader for Jama Connect and the regulated digital thread. The role establishes practical methods that connect user needs, architecture, system and subsystem requirements, risks, design outputs, verification and validation evidence, defects, changes, and released configurations across Jama Connect, Arena, Git Hub Enterprise, SOLIDWORKS/PDM, SharePoint, Smartsheet, Power BI, and related engineering tools. The Systems Architect retains final authority for platform architecture and system-level technical decisions, while the Staff Systems Engineer owns delegated technical work streams, makes consequential domain decisions, and escalates decisions requiring architecture, platform, quality, regulatory, clinical, or business acceptance.

• Lead major systems-engineering work streams spanning multiple projects, disciplines, products, or lifecycle phases, with accountability for coherent technical strategy, integration, review quality, and closure within delegated authority.
• Develop and maintain stakeholder needs, intended-use and use-environment definitions, use cases, product functions, system requirements, requirement attributes, rationale, assumptions, constraints, allocation, acceptance criteria, and verification methods.
• Lead functional decomposition, system context definition, operating-state analysis, interface definition, architecture-supporting analyses, trade studies, integration planning, and technical decision records.
• Maintain end-to-end traceability among needs, requirements, architecture, interfaces, hazards, risk controls, design outputs, verification, validation, defects, dispositions, changes, and released configurations.
• Lead requirements, interface, risk, traceability, evidence-readiness, and change-impact reviews. Identify gaps, conflicting assumptions, orphan requirements, unverified controls, incomplete acceptance logic, and cross-functional dependencies.
• Lead or support complex investigations involving product performance, reliability, software, hardware, disposables, manufacturing, suppliers, service, complaints, CAPAs, NCRs, RMAs, cybersecurity, or regulatory commitments. Separate root cause, contributors, symptoms, and escape mechanisms and drive evidence-based closure.
• Own or lead system-level change-impact assessments addressing performance, safety, usability, reliability, cybersecurity, configuration, V&V, manufacturing, service, labeling, clinical workflow, regulatory evidence, and released-product implications.
• Lead system-level risk integration, including system hazard analysis, use-related risk linkages, cybersecurity system requirements, risk-control requirements, residual-risk evidence, and traceability to verification and validation.
• Lead system verification strategy, requirements verification matrices, evidence-gap assessments, protocol acceptance-criteria alignment, coverage analysis, anomaly reconciliation, and readiness recommendations for design reviews and release decisions.
• Coordinate across R&D, Quality, Regulatory, Operations, Manufacturing, Service, Commercial, Clinical, Product Management, PMO, suppliers, and external partners to ensure one integrated product definition and evidence chain.
• Provide…