Equipment Validation Engineer

Katalyst Healthcares and Life Sciences

Round Lake, IL

Job Summary:

Lab Equipment Validation Engineer responsible for leading validation activities for laboratory equipment supporting infusion system testing in a regulated medical device environment, ensuring compliance with FDA regulations, ISO standards, and quality system requirements.

Roles & Responsibilities:

Lead validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and related test systems).
Develop and execute validation protocols, test plans, and reports in alignment with FDA 21 CFR Part 820, Part 11, ISO 13485, and equipment validation best practices.
Partner with R&D, Quality, and Systems Engineering teams to define equipment validation requirements and risk based strategies.
Perform IQ/OQ/PQ activities for lab equipment and ensure complete traceability from requirements through test execution.
Ensure validated equipment supports all infusion system verification needs including flow accuracy, environmental stress testing, and performance simulation.
Collaborate with hardware, firmware, and systems engineering teams to ensure equipment suitability and proper test coverage.
Investigate and resolve equipment issues discovered during validation or testing activities.
Support calibration, maintenance, and lifecycle management of lab equipment used for infusion system tests.
Drive continuous improvement of validation processes, documentation quality, and lab test methodologies.
Maintain accurate and compliant documentation per Baxter quality systems, design control, and equipment lifecycle standards.

Education & Experience:

Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Computer Engineering, or related technical field.
Minimum 5+ years of experience in equipment validation or software validation within a medical device or FDA regulated environment.
Strong understanding of FDA regulations, ISO 13485, equipment validation, and regulated testing processes.
Hands on experience with lab equipment used in infusion system testing: Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and similar test systems.
Experience with tools such as LabVIEW or Python for automating test data acquisition (as applicable).
Hands on experience with test measurement instruments such as temperature chambers, flow analyzers, pressure sensors, oscilloscopes, and calibration tools.
Understanding of risk management frameworks (ISO 14971).
Experience working within formal document control, change management, and validation documentation systems.
Prior experience validating lab equipment specifically for infusion systems or drug delivery devices.
Knowledge of environmental and stress testing methodologies for medical device performance verification.
Familiarity with data integrity and cybersecurity considerations in lab test environments.
Certifications such as CSQE, CMII, or Lean Six Sigma are a plus.

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Vacancy posted 2 days ago

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