Clinical Research Coordinator, MS degree in Science, Statistics, Management or related & 1 year experience: Internal/ external audits to ensure firm is compliant with ISO 13485 & 21 CFR. Experience in CAPA & Non-conformance to product through product data analysis. Make design changes in Enable/ Agile & Wind-chill to close it through the global review board. Knowledge of compliance with all regulatory & local regulations including US-FDA Pre-market approval, 510K submissions & Supplements. Verify & validate Diabetes insulin pumps per IEC 60601-2-24. Work on CAD/CAE Solid works tools & maintain CAD documents & customized CAD program. Work on Design Controls, Product Life Cycle Management, System Architecture & Simulation based Product Development. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.