Equipment Validation Engineer

Company : Katalyst Healthcares & Life Sciences

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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