Manufacturing Engineer

1 month ago


Fremont, California, United States Qapel Medical Inc Full time

Identify and support the qualificat i on of suppl i ers for materials needed for products.Provide manufacturing engineering expertise in the daily operation and maintenance of the assigned manufacturing processes and related business continuity needs in production and to contract manufacturer as needed.Provide engineering expertise to the design, fabrication , development, installation , validation and qualification of equipment /fixtures per Quality system requirements.Work with Quality Engineering and Production personnel in the conduct of root cause analyses of material and process non-conformances (NCMRs) and implementation of correcti v e actions (CAPAs).Work with R&D and Production personnel to manufacture product for Design Verification and to transfer new products and processes into manufacturing environment in-house or to an external contract manufacturer.Support engineering testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodi e s, as required.Working knowledge of Statistical Process Control (SPC), Six Sigma principals and tools and decis io n-making tools Use CAD software such as Auto cad, Solid works Ability to travel to contract manufacturer, attend training activities, and visit suppliers, etc.The salary offered will depend on internal pay equity and the candidate's relevant skills, experience, qualifications, and job market data.



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