Manufacturing Engineer - Medical Devices at Intellectt Inc Gainesville, FL

Manufacturing Engineer - Medical Devices job at Intellectt Inc. Gainesville, FL. Responsibilities: Review and execute

IQ, OQ, PQ

protocols for equipment and processes. Conduct

process audits

and update

QMS documentation

. Perform

process optimization

using DoE for CNC Machining and DCM. Conduct

validation, verification, and qualification

activities with detailed reporting. Use

statistical tools (Minitab/JMP)

to analyze process performance and variability. Lead

change management

and implement

process improvements

. Support

manufacturing, troubleshooting, and cross-functional teams

on production floor issues. Ensure

compliance with FDA, ISO 13485, and GMP standards

. Requirements: Bachelor’s/Master’s in

Mechanical, Biomedical, or related Engineering

. 8+ years

in

medical device manufacturing

(CNC & DCM experience required). Strong knowledge of

IQ/OQ/PQ, TMV, QMS, and ERP systems

. Skilled in

statistical analysis and problem-solving

. Excellent

communication and documentation

skills.

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