Clinical Systems Engineer

Caris Life Sciences

. Lead and support complex projects involving clinical systems, validation, asset management, risk management, software platforms, and quality processes .

Posted 10/14/2026full-timePhoenix • Arizona • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in risk management, software validation, and quality processes within regulated environments, with a strong focus on laboratory instrumentation and clinical systems. Proficient in project management, analytical thinking, and stakeholder engagement to drive process improvements and compliance.

Highest-signal resume keywords

Computer System ValidationRisk ManagementProject ManagementLean ConceptsQuality System Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk AssessmentChange ControlValidationProcess ImprovementTechnical WritingData MappingAPI-Enabled IntegrationsIssue TrackingLaboratory InstrumentationWorkflow Automation

Soft Skills

Analytical ThinkingProblem-SolvingStakeholder Engagement

Tools & Technologies

CMMSEMSEQMSLISVLMSMicrosoft Office Suite

Certifications & Qualifications

Lean Six Sigma Certification

Industry Keywords

CAPCLIAISO 13485ISO 15189ISO 1497121 CFR Part 820

About the role

Key responsibilities & impact

Lead and support complex projects involving clinical systems, validation, asset management, risk management, software platforms, and quality processes
Develop and maintain risk registers, assessments, mitigation plans, issue logs, action tracking, escalation records, and periodic risk review materials
Facilitate cross-functional risk identification and assessment activities
Integrate risk and issue management into validation, change control, deviation and CAPA support, audit readiness, lifecycle management, and process improvement
Prepare metrics, dashboards, trend reports, and leadership summaries
Administer and improve Equipment Services platforms, including VLMS, CMMS, elogbook, EMS, pipette calibration, and related workflow tools
Provide training, end-user support, troubleshooting, access support, and quality review
Lead software validation, revalidation, periodic review, upgrade assessment, regression testing, release readiness, and controlled deployment
Evaluate potential replacement systems through requirements definition, risk assessment, fit-gap analysis, validation impact, integration needs, implementation effort, and lifecycle cost analysis
Provide project management and technical support for platform interfaces and data integrations
Define business, data, quality, security, validation, and support requirements for APIs and integrations
Coordinate project plans, milestones, actions, decisions, testing, stakeholder communications, implementation readiness, and post-implementation monitoring
Apply systems thinking and lean methods to reduce manual work, eliminate duplicate data entry, improve traceability, and increase reliability
Ensure equipment verification and system records comply with regulatory, accreditation, quality, and company requirements
Analyze dependencies among laboratory instrumentation, operations, IT infrastructure, software, Quality, and validation activities
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 and support remediation of observations
Manage company records according to regulatory requirements, retention schedules, data integrity principles, and company policies
Collaborate across Systems Engineering, Equipment Services, Laboratory Operations, IT, Software, Quality, Validation Engineering, Procurement, Supplier Quality, Quality, and Regulatory teams

Requirements

What you’ll need

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 CAP, CLIA, ISO 13485, ISO 15189, ISO 14971, and 21 CFR Part 820 requirements
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, and Outlook; general working knowledge of Internet for business use
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
Master's degree, Lean Six Sigma certification, and experience with CMMS, EMS, eQMS, LIS, VLMS, calibration, asset management platforms, API-enabled integrations, data mapping, business intelligence tools, interface testing, master-data governance, and project management methods are preferred
Ability to use standard office equipment and sit and stand for extended periods
Ability to work in desk/cubicle and laboratory environments, with possible exposure to high noise levels, fumes, and biohazardous materials
Ability to work some evenings, weekends, and/or holidays

Benefits

Comp & perks

Equal opportunity employer
Pre-employment process includes background check, drug screening, credit check where applicable, and reference verification