Build a dedicated premarket and manufacturing quality organization.

• Mentor fellow team members on best practices for process development, process validation, and documentation.• Acting CAPA mentor to coach owners through process and evaluate each phase before submission.• Acting Problem Solving SME for molding area responsible for supporting engineers with use of problem solving tools, assist with experimental designs to separate effects of potential inputs, and coach through creation of technical reports to document results.• Acting technical… Show more • Mentor fellow team members on best practices for process development, process validation, and documentation.• Acting CAPA mentor to coach owners through process and evaluate each phase before submission.• Acting Problem Solving SME for molding area responsible for supporting engineers with use of problem solving tools, assist with experimental designs to separate effects of potential inputs, and coach through creation of technical reports to document results.• Acting technical lead responsible for identifying state of the art solutions for a site wide strategic project to insource metal processing equipment such as Laser Cutters, Precision Grinders, Swiss Lathes, and Passivation baths.• Supervise technician and identify opportunities for career development of promising resource.• Work with multifunctional team to put systems in place and train employees to new validation requirements and procedures. Show less

• Consistently implemented qualified and validated manufacturing processes before deadline.• Repeatedly recognized as a performer through selection as a team member for high priority projects.• Isolated and corrected design and manufacturing related issues (internal and external) and inefficiencies through identification of root cause(s), process improvement techniques and Design of Experiment Methodology. • Lead Manufacturing Engineer for new product development project that was… Show more • Consistently implemented qualified and validated manufacturing processes before deadline.• Repeatedly recognized as a performer through selection as a team member for high priority projects.• Isolated and corrected design and manufacturing related issues (internal and external) and inefficiencies through identification of root cause(s), process improvement techniques and Design of Experiment Methodology. • Lead Manufacturing Engineer for new product development project that was driven from inception to market by a cross functional team in 6 months when initial project timeline spanned 12 months.• Investigated manufacturing related complaint and work with equipment engineering group to implement new equipment as a corrective action. Show less

• Identified and performed proof of concept testing on Off-The-Shelf pieces of equipment in order to improve ergonomics & safety, process control, cycle time and yield of manufacturing processes.• Designed and developed specialized fixtures and equipment alone and in cross functional teams.• Applied technical writing skills to generate research protocols and report results.• Validated in-process test methods and manufacturing process changes to applicable standards.• Developed… Show more • Identified and performed proof of concept testing on Off-The-Shelf pieces of equipment in order to improve ergonomics & safety, process control, cycle time and yield of manufacturing processes.• Designed and developed specialized fixtures and equipment alone and in cross functional teams.• Applied technical writing skills to generate research protocols and report results.• Validated in-process test methods and manufacturing process changes to applicable standards.• Developed project plans, tracked accomplishments and reported progress and road blocks to management. Show less

• Designed, developed and validated test methods, fixtures and programs for the assessment of critical to quality dimensions of molded components.• Wrote and executed IQ, OQ and PQ protocols for validation of manufacturing processes and equipment, analyzed the data using statistical techniques (Minitab) and documented results through written reports.• Managed assigned resources for testing.• Worked with team to guarantee all testing and reports complete by project deadline.