Senior Clinical Systems Engineer: Risk & Validation

Caris Life Sciences; Phoenix (AZ); On-site; USD 110,000 - 150,000; Full time

Job summary

Caris Life Sciences in Phoenix, AZ, seeks a Clinical Systems Engineer to lead and support complex projects involving clinical systems, validation, asset management, risk management, software platforms, and quality processes.

You will apply systems thinking, risk-based decision‑making, lean concepts, and project management to improve governance, automate workflows, integrate platforms, and support lifecycle programs in LDT/GMP environments.

Qualifications

• Bachelor's degree in engineering, biological science, computer science, information systems, or a related field.
• Experience with computer system validation, laboratory instrumentation, or clinical/software systems administration.
• Knowledge of quality systems and risk-based practices (CAP, CLIA, ISO 13485, ISO 15189, ISO 14971, 21 CFR Part 820).

Responsibilities

• Develop, implement, and maintain risk registers and mitigation plans.
• Lead cross-functional risk identification and assessment activities.
• Support risk-based quality requirements and CAPA, change control, and audit readiness.
• Integrate risk management with equipment validation and software governance.
• Prepare metrics and leadership summaries on open risks and program performance.
• Provide training, end-user support, and overall lifecycle management for platforms.
• Coordinate project plans and stakeholder communications for initiatives.

Skills

Systems thinking

Lean concepts

Project management

Regulatory compliance

Risk assessment & CAPA

Education

Bachelor's degree in engineering/biological sciences/CS/IS

Master's degree preferred

Tools

CMMS

VLMS

EMS

LIS

eQMS

Asset management platforms

Job description

Caris Life Sciences in Phoenix, AZ, seeks a Clinical Systems Engineer to lead and support complex projects involving clinical systems, validation, asset management, risk management, software platforms, and quality processes.

You will apply systems thinking, risk-based decision‑making, lean concepts, and project management to improve governance, automate workflows, integrate platforms, and support lifecycle programs in LDT/GMP environments.