Mechanical Design Engineer
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POST DATE 9/16/2016
END DATE 11/19/2016
Entegee Engineering Technical Group
JOB DESCRIPTIONThe Mechanical Engineer will provide technical engineering leadership in the support of medical device instruments during the investigation, definition, design, development, and qualification phases. Utilizing SolidWorks CAD and design analysis tools, the incumbent establishes: mechanical engineering specifications, identifying critical design factors and risks that meet customer needs and regulatory requirements; designs systems and sub-systems; conducts theoretical and empirical analyses of complex core technology or mechanical systems; reviews overall design, specifications and experimental designs to ensure efficacy, feasibility and compliance; participates on multi-mechanical engineering development teams; and lead teams to improve product designs and/or resolve issues. Qualifications Skill Requirements: ? Knowledge of FDA/ISO quality systems (specifically Design Controls/Product Realization) and related requirements ? Understanding of product development and manufacturing methodologies to achieve high quality design (design for reliability) ? Medical device experience desired ? Demonstrated skill in the areas required to perform this job: o Mechanical design and analysis using CAD (Solidworks strongly preferred) o Design for reliability/manufacturability o CAPA o Materials and component selection o Test fixture design o Hydro pneumatic and fluidic subsystem design o Characterization, verification and validation activities o Excellent communication, writing, and presenta
Bachelor's degreeKnowledge of FDA/ISO quality systemsCADCAPA
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