Product Engineer

Conduct IQ/OQ/PQ validation of\nmachinery to enhance quality control and ensure regulatory compliance; Develop\nassembly procedures and review mechanical manufacturing processes to meet\nquality assurance standards and ensure dimensional accuracy of medical devices;\nPerform product evaluation using Advanced CAD/CAM, SolidWorks, and statistical\nanalysis.<\/span>
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Conduct Finite Element Analysis (FEA) using 2D/3D simulations to\nassess mechanical performance and stress tolerances; Define critical, major,\nand minor characteristics for assemblies and parts to ensure compliance with\nquality assurance provisions; Conduct internal audits and develop technical\nguidelines to meet ISO Standards and support annual audits; Evaluate\nnon\-conforming parts for compliance with engineering standards and determine\nwhether modification or rejection is necessary; Develop and implement quality\nassurance programs including engineering materials performance.<\/span>
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Conduct CAPA\ninvestigations and collaborate with cross\-functional teams to enhance product\nquality and process reliability, applying principles of Kinematics and dynamics\nof machinery; Monitor gauge calibration and creation, ensuring measurement\nprecision and adherence to GD&T standards; Establish calibration procedures\nfor inspection instruments. <\/span><\/span>
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Requirements<\/h3>
Must have a Bachelor\u2019s Degree in\nMechanical Engineering or Biomedical Engineering plus skills and knowledge of\nAdvanced CAD/CAM, Solidworks, Material Performance, FEA, Statistical Analysis,\nKinematics and dynamics of machinery, mechanical manufacturing processes.

Job Location : St Petersburg,FL. Submit resume referencing job code HAL003 to HR, SS White Tech, 8300 Sheen Dr, St Petersburg, FL 33709

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