Description: Our client is currently seeking an Engineer Senior
Preferred Qualifications: • M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering • Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment • Experience with managing technical teams, including setting priorities and leveling resources • Technical writing experience • Spanish language skills preferred • Experienced with SolidWorks (or other 3D-CAD software) • Familiar with equipment and software IOQ • Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs • Experience with change controls, deviations, CAPA • Experience with combination products and device regulatory requirements • Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems • Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing • Experience with machine controls (PLC, HMI) and vision systems
Contact: skumar09@judge.com
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