Lafayette, Colorado30+ days ago
Requires a minimum of 2 years of experience in each of the following: FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software Development Life Cycle); Collaborating with international team members; MS projects using Monte Carlo simulation; SAP S/4HANA, SAP ECC and HP ALM; IQ, OQ and PQ; Design for Injection Molding, extrusion, CNC machining and Tolerance stack up analysis; PTC Creo, Minitab, Solidworks and Auto CAD; DOE, CAPA and NCMR; and Working with Cerebrospinal Fluid (CSF) products. Bachelor’s degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and five (5) years of experience as a manufacturing engineer or related engineering occupation; OR Master’s degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and two (2) years of experience as manufacturing engineer or related engineering occupation.