Clinical Systems Engineer (Hybrid)

Caris Life Sciences•Phoenix, AZ

5d•Hybrid

About The Position

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary The Clinical Systems Engineer (CSE) leads and supports complex projects involving clinical systems, validation, asset management, risk management, software platforms, and quality processes. The role applies systems thinking, risk-based decision-making, lean concepts, and project management practices to improve system governance, automate workflows, integrate platforms, strengthen issue management, and support compliant equipment lifecycle programs within laboratory developed test (LDT) and good manufacturing practice (GMP) laboratory environments. Working under the direction of the Systems Engineering leadership, this position serves as a key technical contributor to the Equipment Services risk and issue management programs. The CSE develops and maintains program tools and records, performs and facilitates risk assessments, supports issue management and closure, and helps embed risk-based approaches into validation, change management, CAPA, PM/calibration, system administration, and continuous improvement activities.

Requirements

Bachelor's degree in engineering, biological science, computer science, information systems, or a related field.
Demonstrated experience with computer system validation, laboratory instrumentation, clinical or enterprise software administration, systems engineering approaches, workflow automation, or system integration.
Working knowledge of quality management system requirements and risk-based practices applicable to regulated laboratory or medical device environments, including CAP, CLIA, ISO 13485, ISO 15189, ISO 14971, and 21 CFR Part 820.
Experience supporting risk assessments, issue management, CAPA, change control, validation, periodic review, audit readiness, or other quality-system processes.
Ability to translate operational and compliance needs into system requirements, controlled configurations, workflows, test cases, reports, and sustainable support processes.
Strong project management, analytical thinking, technical writing, stakeholder engagement, and problem-solving skills.
Proficiency in lean concepts, process improvement, GAMP 5, risk-based critical thinking, change management, and issue tracking.
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.

Nice To Haves

Master's degree in biological science, chemistry, engineering, computer science, information systems, or a related field.
Lean Six Sigma certification.
Experience with CMMS, EMS, eQMS, LIS, VLMS, calibration, or asset management platforms.
Experience with API-enabled integrations, data mapping, business intelligence tools, interface testing, or master-data governance.
Proficiency in Agile, Scrum, Waterfall, Kanban, and lean project management methods.
Two or more years of experience in a quality, engineering, validation, systems, or laboratory role within a regulated environment, with a focus on laboratory instrumentation, equipment, or clinical systems.

Responsibilities

Develop, administer, and maintain risk management tools and records, including risk registers, risk assessments, risk control and mitigation plans, issue logs, action tracking, risk acceptance documentation, escalation records, and periodic risk review materials.
Facilitate cross-functional risk identification and assessment activities using approved methodologies, ensuring hazards, failure modes, business impacts, compliance impacts, data integrity concerns, and operational dependencies are documented and evaluated consistently.
Support application of risk-based approaches consistent with applicable CAP, CLIA, ISO 13485, ISO 15189, ISO 14971, ISO 22367, FDA 21 CFR Part 820, and internal quality system requirements.
Integrate risk and issue management activities into equipment validation, computer system validation, software governance, change control, deviation and CAPA support, audit readiness, lifecycle management, and process improvement.
Prepare metrics, dashboards, trend reports, and leadership summaries that provide visibility into open risks, systemic issues, mitigation effectiveness, aging actions, and program performance.
Administer and continuously improve Equipment Services platforms, including the VLMS, CMMS, elogbook, EMS, pipette calibration, and related workflow tools.
Partner with stakeholders to improve usability, data quality, workflow delineation by site or building, role-based processes, reporting, and adoption of clinical systems.
Perform ongoing system audits to verify that preventive maintenance, calibration, equipment records, and elogbook activities remain aligned with applicable SOPs, equipment manuals, quality requirements, and approved configurations.
Provide training, end-user support, troubleshooting, access support, and quality review for platforms owned or supported by Equipment Services.
Lead software validation, revalidation, periodic review, upgrade assessment, regression testing, release readiness, and controlled deployment for Equipment Services platforms.
Participate in the evaluation and vetting of potential replacement systems, including requirements definition, risk assessment, fit-gap analysis, validation impact, integration needs, implementation effort, and lifecycle cost considerations.
Provide project management and technical support for interfaces and data integrations involving various platforms (e.g., Limble, Tableau, Oracle, LIS, EMS, LabLogs, Dot Compliance, Calibry, PipetteX, and Kneat).
Define business, data, quality, security, validation, and support requirements for APIs and system integrations in partnership with IT, Software, Quality, Validation Engineering, Laboratory Operations, Automation, Procurement, and other stakeholders.
Coordinate project plans, milestones, actions, decisions, testing, stakeholder communications, implementation readiness, and post-implementation monitoring for assigned initiatives.
Apply systems thinking and lean methods to harmonize requirements, reduce manual work, eliminate duplicate data entry, improve traceability, and increase reliability across the equipment-management ecosystem.
Ensure equipment verification and system records comply with applicable regulatory, accreditation, quality, and company requirements, including CLIA, CAP, NYS, ISO, FDA, and IVDR requirements, as applicable.
Analyze dependencies among laboratory instrumentation, operations, IT infrastructure, software, Quality, and validation activities to define and execute compliant projects within equipment validation, maintenance, and calibration programs.
Author, review, revise, and implement SOPs, work instructions, validation documents, system requirements, risk records, test scripts, training materials, and governance documentation.
Participate in internal and external audits by preparing evidence, retrieving records, explaining system controls and workflows, responding to questions, and supporting timely remediation of observations.
Manage company records in accordance with regulatory requirements, retention schedules, data integrity principles, and company policies.
Engage in cross-functional collaboration across Systems Engineering, Equipment Services, Laboratory Operations, IT, Software, Software Quality Assurance, Validation Engineering, Procurement, Supplier Quality, Quality, and Regulatory teams.