Bachelors degree in Biomedical, Mechanical or Electrical Engineering or related field willing to accept foreign education equivalent plus five 5 years of experience in job or in design control level development of endodontic devices through commercial launch or, alternatively, a Masters degree in Biomedical, Mechanical or Electrical Engineering or related field willing to accept foreign education equivalent and two years 2 of experience in job or in design control level development of endodontic devices through commercial launch. Experience must include Medical device design and manufacturing of stainless steel and nitinol endodontic products; Materials testing and test method development for endodontic nitinol files; Engineering change control procedures and working through phasegated product development process; SolidWorks and CAD modeling programs for drawing standards; Conducting tolerance stackup analysis and of complex electromechanical devices; Working with ISO standards, quality systems, regulations and documentation practices including 21CFR820, ISO 13485, ISO 14971, and EU Medical Device requirements Council Directive, 9342EEC; and Two 2 years Class I and II endodontic product design control level experience in all phases of development including successful commercial launch. Requires travel up to 10 domestic and international travel.
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