Clinical Systems Engineer (Hybrid)

Caris Life Sciences•Phoenix, AZ

3d•Hybrid

About The Position

The Clinical Systems Engineer 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 Systems Engineering leadership, the position is a key technical contributor to Equipment Services risk and issue management programs. The engineer develops and maintains program tools and records, performs and facilitates risk assessments, supports issue management and closure, and embeds risk-based approaches in validation, change management, CAPA, preventive maintenance and 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 for 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.
Proficiency in Microsoft Office Suite, specifically Word, Excel, and Outlook, and general working knowledge of the 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, focused on laboratory instrumentation, equipment, or clinical systems.

Responsibilities

Develop, administer, and maintain risk management tools and records, including risk registers, risk assessments, control and mitigation plans, issue logs, action tracking, risk acceptance documentation, escalation records, and periodic review materials.
Facilitate cross-functional risk identification and assessment, documenting and evaluating hazards, failure modes, business and compliance impacts, data integrity concerns, and operational dependencies using approved methodologies.
Support risk-based practices consistent with applicable regulatory, accreditation, and internal quality system requirements.
Integrate risk and issue management into equipment and 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 on open risks, systemic issues, mitigation effectiveness, aging actions, and program performance.
Administer and improve Equipment Services platforms, including VLMS, CMMS, elogbook, EMS, pipette calibration, and related workflow tools.
Partner with stakeholders to improve platform usability, data quality, site- or building-specific workflows, role-based processes, reporting, and adoption.
Conduct system audits to verify preventive maintenance, calibration, equipment records, and elogbook activities align with 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.
Evaluate potential replacement systems, including requirements definition, risk assessment, fit-gap analysis, validation impact, integration needs, implementation effort, and lifecycle costs.
Provide project management and technical support for interfaces and data integrations involving platforms such as 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 with cross-functional partners.
Coordinate project plans, milestones, actions, decisions, testing, stakeholder communications, implementation readiness, and post-implementation monitoring.
Apply systems thinking and lean methods to harmonize requirements, reduce manual work and 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 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.
Support internal and external audits by preparing evidence, retrieving records, explaining system controls and workflows, responding to questions, and supporting timely remediation.
Manage company records in accordance with regulatory requirements, retention schedules, data integrity principles, and company policies.
Collaborate across Systems Engineering, Equipment Services, Laboratory Operations, IT, Software, Software Quality Assurance, Validation Engineering, Procurement, Supplier Quality, Quality, and Regulatory teams.
Use standard office equipment; sit and stand for extended periods. Work between a desk/cubicle and laboratory environment, where exposure to high noise levels, fumes, and biohazardous materials may occur.
Attend job-specific, safety, and compliance training assigned based on job functions.
Work some evenings, weekends, and/or holidays.
Successfully complete the pre-employment process, including criminal background check, drug screening, applicable credit check, and reference verification.