Roles & Responsibilities: Design Quality, Good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process. EIS : Medical Device & Regulations. GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) and regulatory affairs. Strong creative, analytical and problem-solving skills. Proficient at interpreting data and putting that data into a report. Proficient at statistical analysis. Root Cause Analysis. Strong CAD Skills (Preferred Auto CAD and Solidworks). GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) and regulatory affairs. Strong creative, analytical and problem-solving skills. Proficient at interpreting data and putting that data into a report. Proficient at statistical analysis. Root Cause Analysis. Strong CAD Skills (Preferred Auto CAD and SolidWorks). Strong Fixture design skill. Experience in creating FMEAs & Writing reports. Experience in PMS (Post Market Surveillance). Experience in PLM Tool (Windchill). Process experience, ability to observe and understand manufacturing processes. Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred. Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software. Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.).