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Manufacturing Engineer - Medical Devices at Intellectt Inc Gainesville, FL
Manufacturing Engineer - Medical Devices at Intellectt Inc Gainesville, FLIntellectt Inc • Gainesville, FL, US
Manufacturing Engineer - Medical Devices at Intellectt Inc Gainesville, FL

Manufacturing Engineer - Medical Devices at Intellectt Inc Gainesville, FL

Intellectt Inc • Gainesville, FL, US
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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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    Manufacturing Engineer • Gainesville, FL, US

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