COVIDIEN – $143,262.00/Year

Complete requirements for the position are as followsbr br Masters degree in Biomedical or Mechanical Engineering and three years of experience in engineering project management in the medical device field or Bachelors degree in Biomedical or Mechanical Engineering and five years of experience in engineering project management in the medical device field.br br Must possess a minimum of three 3 years of experience with each of the following Design development, Design controls and Design History File; statistical data analysis, utilizing tools to include Six Sigma and Minitab; Risk Assessment and Risk Management, including Failure Modes Effects Analysis FMEA and root cause analysis; design verification and validation activities, including Biocompatibility, Sterilization and Materials of Concern; Original Equipment Manufacturing OEM and Contract manufacturing CM Qualifications; Contributing and Supporting regulatory submissions including EU MDDMDR and FDA; and ISO 13485, IEC623661, ANSIAAMI HE75, ISTA, ASTMD4169, ISO 14971 and ISO 10993.