Job Description Must possess knowledge of theoretical and practical fundamentals and experimental engineering techniques. Knowledge on Quality Management and its tools & techniques Knowledge about FDA, 21CFR211 & 820, ISO 13485, ISO 14971, ISO 17025 and compliance regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge of statistics and Minitab. Knowledge of SolidWorks / CAD to perform changes and revise drawings Have first-hand knowledge/experience in creating process flow map, developing project plan using MS Project Gantt’s, Organize and Manage individual project plan/schedule Six Sigma Certified preferred Knowledge on Plastic Molding, Supplier Management, Packaging, Labeling, 510k submission, Project Risk Management, Verification and Validation Presentation to Senior Management Excellent Interpersonal / communication skills, Organizational / planning and Project management skills Understanding of Marketing & market research strategies Per...