Manufacturing Engineer - Medical Devices at Intellectt Inc Gainesville, FLIntellectt Inc • Gainesville, FL, US
Manufacturing Engineer - Medical Devices at Intellectt Inc Gainesville, FL
Intellectt Inc • Gainesville, FL, US
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job_description.job_card.job_descriptionBachelor'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.
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 :
J-18808-Ljbffr
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Manufacturing Engineer • Gainesville, FL, US
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