Design Engineer

Role Description:

Design Quality, Good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process

Competencies:

EIS : Medical Device & Regulations

Experience (Years):

4-6

Essential Skills:

A Minimum Bachelors Degree in Engineering, Science or related technical field5+ years of experience & demonstrated proficiency in Design Quality & providing ongoing technical support is preferred

Desirable Skills:

? Knowledge on Quality Management and its tools & techniques? Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations? Knowledge on Medical Device Regulatory Standards, MDD and MDR? Knowledge on NC, CAPA, Root Cause Analysis and Audit processes? Knowledge in Statistics, Risk Management and Design control? Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills? Experience in creating FMEAs & Writing reports? Experience in PMS (Post Market Surveillance)? Experience in PLM Tool (Windchill)? Good understanding of Design, Drawing and GD&T? 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.)