Job Description:

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 equipmen...