Staff Systems Engineer

Description

ABOUT THE COMPANY

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. LifePort 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.

POSITION SUMMARY

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 workstreams 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, GitHub 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 workstreams, makes consequential domain decisions, and escalates decisions requiring architecture, platform, quality, regulatory, clinical, or business acceptance.

PRIMARY (ESSENTIAL) FUNCTIONS

• Lead major systems-engineering workstreams 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 technical review and recommendations for design inputs and outputs, risk-management records, protocols, reports, technical assessments, submission-support content, DHF/DMR applicability, and released configuration evidence.
• Lead training, coaching, and reusable method development for requirements writing, traceability, review preparation, change impact, risk integration, verification evidence, defect disposition, and systems thinking.
• Create and improve templates, checklists, workflows, metrics, scripts, dashboards, review practices, and working instructions that reduce dependence on individual heroics and increase consistency across ORS.

JAMA CONNECT AND DIGITAL ENGINEERING RESPONSIBILITIES

• Serve as a Jama Connect power user and systems-engineering process leader. Configure and govern approved components, item types, relationship rules, attributes, workflows, views, filters, baselines, reviews, dashboards, and coverage reports in partnership with Systems Architecture, Quality, Regulatory, and functional engineering leaders.
• Translate approved product and system decomposition into a usable Jama information architecture without silently changing approved requirements or controlled baselines.
• Plan and lead migration, reconciliation, cleanup, and quality review of legacy requirements and evidence from Word, Arena, spreadsheets, MatrixOne, and other sources. Preserve source, revision, approval status, rationale, and unresolved gaps.
• Establish and monitor Jama data-quality expectations, including naming, atomicity, rationale, allocation, verification method, status, ownership, relationship completeness, suspect-link resolution, baseline discipline, review closure, and traceability coverage.
• Use Jama as the working system for requirements, risk-control relationships, test cases and runs, engineering defects and dispositions, baselines, reviews, coverage analysis, and impact analysis. Ensure final approved outputs are transferred or referenced through the applicable controlled Arena process.
• Maintain controlled linkages between Jama requirements and defects and GitHub issues, branches, pull requests, commits, test results, cybersecurity findings, release tags, checksums, SBOM summaries, and software release evidence.
• Preserve source-of-truth boundaries: Jama for active systems engineering and traceability, GitHub Enterprise for software and firmware implementation evidence, Arena for controlled PLM/QMS and released records, SOLIDWORKS/PDM for mechanical design geometry, and SharePoint/Microsoft 365 for approved knowledge and collaboration content.
• Develop Jama training materials, role-based guidance, examples, office hours, and onboarding support. Coach teams until they can use workflows correctly without unnecessary administrative burden.
• Partner with Power BI, Smartsheet, SharePoint, Microsoft 365 Copilot, and automation owners to improve visibility, searchability, metrics, and decision support while preserving access controls, validation boundaries, auditability, and controlled-record requirements.
• Use AI-enabled engineering tools responsibly to accelerate discovery, analysis, drafting, review preparation, and knowledge reuse. Ensure engineering decisions and regulated evidence receive appropriate human review and approval.

Requirements

Education / Training / Certifications / Licenses

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Software/Computer Engineering, Computer Science, or a closely related technical or scientific discipline. ABET-accredited engineering degree preferred.
• Documented education-and-experience equivalency may be considered through the ORS R&D and HR review process.
• Master's degree in Systems Engineering or a related technical discipline is preferred but not required.
• INCOSE certification, Jama certification or formal administration training, ISO 14971 training, design-control training, or equivalent credentials are preferred.

Experience

• Eight or more years of progressively responsible engineering experience, with sustained Staff-level scope demonstrated through major subsystem, multi-project, or cross-functional technical leadership. Experience is a guide; demonstrated capability, judgment, and impact determine level.
• Demonstrated systems-engineering experience with stakeholder needs, requirements decomposition, architecture and interfaces, traceability, risk integration, verification planning, change impact, integration, and lifecycle management.
• Advanced proficiency with Jama Connect or a comparable requirements-and-test-management platform, including information architecture, relationship models, baselines, reviews, workflows, filters, dashboards, coverage analysis, migration, and data-quality governance.
• Experience developing or sustaining complex electro-mechanical, software-enabled, connected, or similarly multidisciplinary regulated products. Medical-device experience strongly preferred.
• Experience with design controls, ISO 14971 risk management, V&V, configuration management, technical documentation, change control, investigations, and submission or audit support.
• Experience leading cross-functional technical reviews, complex investigations, outsourced engineering work, suppliers, or external development partners.
• Demonstrated experience mentoring, training, and improving the effectiveness of other engineers.

Skills / Abilities

• Deep systems thinking and the ability to connect intended use, clinical workflow, product functions, requirements, architecture, interfaces, risk controls, design outputs, evidence, configuration, and lifecycle consequences.
• Strong requirements-writing, traceability, facilitation, review, technical decision, and change-impact skills.
• Strong technical judgment, structured problem solving, root-cause analysis, and ability to separate evidence, assumption, hypothesis, uncertainty, and recommendation.
• Ability to lead through influence, resolve cross-functional ambiguity, constructively challenge weak evidence, and escal...
• Ability to communicate complex technical and regulatory information clearly to technical and nontechnical audiences.
• Working knowledge of Arena PLM/QMS, GitHub Enterprise, SOLIDWORKS/PDM, SharePoint/Microsoft 365, Smartsheet, Power BI, and regulated tool-validation or intended-use concepts is preferred.
• Ability to develop practical training, templates, workflows, metrics, and reusable methods that support adoption without unnecessary bureaucracy.
• Commitment to patient and customer impact, evidence-based decisions, accountability, collaboration, technical rigor, continuous learning, and responsible use of AI.

Benefits & Perks

Annual incentive bonus opportunity

Comprehensive medical, dental, and vision coverage

Company-paid life insurance, short-term disability, and long-term disability coverage

Flexible Spending Accounts (Health & Dependent Care FSA)

401(k) with 100% company match on the first 5% of employee contributions

Company-paid life insurance and disability coverage

Generous paid time off, including vacation, sick, personal, volunteer time, and paid holidays

Paid parental leave

Summer hours program

Tuition reimbursement and professional development support

Employee Assistance Program (EAP) and identity theft protection

Pet insurance and legal plan options

Technology and wellness reimbursement

STEM scholarship program

Why Join Us?

At Organ Recovery Systems, we invest in our people by providing competitive benefits that support your health, financial well-being, career growth, and life outside of work.

• Annual Incentive Bonus Opportunity
• Comprehensive Medical, Dental & Vision Coverage
• Company-Paid Life Insurance, Short-Term & Long-Term Disability Coverage
• Flexible Spending Accounts (Health & Dependent Care FSA)
• 401(k) with 100% Company Match on the First 5% of Contributions
• Generous Paid Time Off, Including Vacation, Sick, Personal, Volunteer Time & Paid Holidays
• Paid Parental Leave
• Summer Hours Program
• Tuition Reimbursement & Professional Development Support
• Employee Assistance Program (EAP) & Identity Theft Protection
• Pet Insurance & Legal Plan Options
• Technology & Wellness Reimbursement
• STEM Scholarship Program for Eligible Dependents
• A Culture Focused on Employee Well-Being, Growth, and Work-Life Balance