New product and process development for contact lenses:•Performed development activities on a new high volume pilot production line (12mm lenses per year capacity) to support initial launch. Performed equipment qualifications as needed.•Provided yield improvement support to meet demand for first year product launch.•Performed technology transfer from pilot line to new full production line (48mm lenses per year capacity) for validation readiness.•Process lead for continuous improvement activities with focus on production yield.• Technical lead for metrology improvement project for the measurement of contact lenses

Responsibilities cover all phases of design control relating to process optimization and scale-up projects for Class II medical devices. Processes involve chemical solutions and reactions, liquid-solid separation, freeze drying, powder milling, and blending. Provide technical lead, project management, design, execution, and technology transfer of new or existing processes for optimization and scale-up from R&D to ManufacturingResponsible for equipment identification, procurement, validation protocols and reports (IQ/OQ/PQ) Oversee change order requests (ECO/DCO) and modifies or creates SOPs, validation master plans, risk assessments, process and product FMEAs, quality plans, flow diagrams, and design history files Working knowledge of ISO 13485 and 21 CFR 820Develop processes using statistical tools and robustness studies to ensure minimal defects and SPC Evaluate stability study impact for process changes and initiate/ manage new studies as neededProcess, facility and product improvement opportunities are evaluated to streamline processes, reduce future cost and meet marketing forecasts.Interact with Manufacturing and Quality for change order requests, troubleshooting, statistical evaluation of process outputs, gap analysis, and audit responseTest methods and analysis systems are developed/ qualified/ validated as needed to successfully evaluate new product/ process outputs Product formulation review and optimization to meet customer needsManage biocompatibility studies with assistance from regulatory for new material contact, products or processes to ensure patient safetyProvide oversight/ design for facility upgrade project by working with architects and contractorsManage the R&D laboratories including chemicals and hazardous waste Training/ mentoring of employees on various aspects such as GxP, experimental design, statistical analysis, lab experiment setup, safety, and computer software.