Sr. Quality Engineer - Hardware
REQUIREMENTS:
Masters’ Degree in Electrical or Biomedical Engineering and two (2) years of experience in design quality engineering for hardware and two (2) years of post-bachelor’s progressive experience in all of the following: Medical device product development utilizing FDA design controls and FDA 21 CFR 820; Statistical techniques and data analysis for design verification reports and process validation; Risk activities to include DFMEA, PFMEA, Hazard Analysis ISO 14971 and process & design of FMEAs; CAPA for post market analysis, ISO 13485, EUMDR and supporting both internal & external regulatory audits and inspections; FDA production and process controls (P&PC), planning of process validation & test method validation; Design verification testing, test method development and test method validation per IEC 62304 and IEC 60601-1; Generating master validation plans, reports and design transfer activities, including transitioning development projects to manufacturing.
