Manufacturing Engineer

Santa Clara, CA | Direct

Job ID: 7625 Category: Manufacturing Engineer

Qualifications; 

  • BSME or Industrial Engineering, MS preferred
  • Medical Device
  • SolidWorks 2016
  • Familiarity ISO13485 and 21CFR820
  • Proven experience with process improvement and project management
  • Strong analytical skills and good decision making 
  • Experience in supplier qualification and selection
  • Strong background in quality manufacturing processes including capacity and cost control
  • Demonstrated production experience in a Clean Room environment
  • Ability to travel to visit supplier on an as needed basis
  • Strong written and verbal communication skills and interpersonal skills

Responsibility

  • Oversee/conduct project transfers through whole project life cycle
  • Assist team by evaluating designs to assure DFM, DFT & cost optimization while also developing semi-automated equipment into production
  • Train and lead technicians to ensure product is developed to documented quality standards
  • Identify opportunities for cost efficiency and provide plans to management
  • Ensure true "root-cause" analysis and corrective action within project
  • Transer the Quality documents as necessary: pFMEA, Special Process Validations, FAI, Cpk, MPI's, EFT's, IQ, OQ, PQ
  •  
medical device, ISO13485

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