Complete requirements for the position are as followsbr Bachelors degree or foreign equivalent in Biomedical or Mechanical Engineering or related engineering degree and 5 years progressive experience as RD engineer or related occupation for medical devices, ORbr Masters degree or foreign equivalent in Biomedical or Mechanical Engineering or related engineering degree and 3 years experience as RD engineer or related occupation for medical devices.br br Must also possess at least 3 years of experience with each of the following Supporting global customerfacing events to include product demos, concept feedback sessions and physician interviews; Voice collection, need translation, and product requirement generation for the design and development of medical devices and medical device patents; Designing, coordinating and execution of preclinical trials and physician and customer training; Design, Reliability, Manufacturability methodology and statistical methods; Predictive Product Design and modelling; Design, development and testing of transcatheter structural heart devices and their use in the Clinical setting; FMEAs, risk analysis, CAPA, design verification and validation, root cause analysis, tolerance analysis, and test method validation; FDA 510k and PMA, andor CE mark approval andor guidance; Standard medical device materials and methods including Polymers.
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