Manufacturing Engineer - Medical Devices Job at Intellectt Inc, Gainesville, FL

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  • Intellectt Inc
  • Gainesville, FL

Job Description

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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