Held several roles within R&D and Manufacturing teams within the Diabetes division of Medtronic. Experience ranges from leading small-scale prototype development teams, process engineering, product development, product support engineering, and project management.Key experience includes:- Conducting process characterization Design of Experiments (DOE) to model statistically significant critical to quality performance inputs.- Leveraging characterization DOE models to establish optimal process and environmental inputs to improve process stability and capability. - Process validation (IQ/OQ/PQ) and Test Method Validation (TMV) in compliance with FDA-CFR Part 820 and ISO 13485.- Building and maintaining relationships with suppliers and contract manufacturers for sensor materials and assembly components. Ensured that material and component specifications were rigorous and effective in preventing non-conformance.- Establishing pilot manufacturing lines to support prototype sensor development. Successfully scaled-up prototype lines to support increased clinical supply demands.- Creating Bill of Materials (BOMs) for sensor sub-assemblies through full assemblies. - Creating schedules and trackers for release of traceable sensor parts, BOMs, and all related engineering documentation to meet critical project milestones.- Developing product specifications (sub-system through system level).- Cross-functional collaboration.- Training and mentoring of junior staff and technicians to support technical efforts.- Project Management (all stages: Initiating, Planning, Executing, Monitoring & Controlling, Closing).- Technical report writing.- Manufacturing transfer (pilot lines to full-scale production lines).- R&D support of human feasibility clinical studies in compliance with the principles of Good Clinical Practice (GCP).- Comfortable working in an ISO Class 7 clean room.