Summary:Worked with leaders of the medical device industry providing Regulatory and Quality solutions.Responsibilities:Leading Orthopedic Medical Device Manufacturer• Developed and remediated Risk Management Files in an effort to comply with with updated EU MDR regulations.• Collaborated with cross-functional teams on various Product Development, Risk Management, and Post-Market Surveillance documents.Leading Respiratory Care Medical Device Manufacturer•… Show more Summary:Worked with leaders of the medical device industry providing Regulatory and Quality solutions.Responsibilities:Leading Orthopedic Medical Device Manufacturer• Developed and remediated Risk Management Files in an effort to comply with with updated EU MDR regulations.• Collaborated with cross-functional teams on various Product Development, Risk Management, and Post-Market Surveillance documents.Leading Respiratory Care Medical Device Manufacturer• Facilitated Corrections and Removals for multiple Respiratory Care products. Show less

Summary:Worked in cross-functional teams on the design, development, and manufacture of class I and class II medical devices in accordance with ISO 13485, 21CFR820, and the EU MDR.Responsibilities:• Developed and utilized Risk Management Plans, Master Validation Plans, Design Inputs/Outputs, and other design control tools for multiple OEM devices.• Developed validation protocols for components and assemblies.• Supported internal and supplier process validations for… Show more Summary:Worked in cross-functional teams on the design, development, and manufacture of class I and class II medical devices in accordance with ISO 13485, 21CFR820, and the EU MDR.Responsibilities:• Developed and utilized Risk Management Plans, Master Validation Plans, Design Inputs/Outputs, and other design control tools for multiple OEM devices.• Developed validation protocols for components and assemblies.• Supported internal and supplier process validations for processes such as Plastic Injection Molding, Part Cleaning, Laser Etching/Marking, Wire Electrical Discharge Machining, and Finished Device Assembly.• Supported packaging validations including Heat Seal Validations, Sterilization Validations, and Shelf-Life Testing.• Supported project scheduling and identifying schedule improvements throughout the product development process from design freeze to product launch.• Worked with cross-functional teams on internal, supplier, and customer corrective actions.• Managed sterility assurance testing for both OEM and CM devices.• Project Manager for multiple Continuous Improvement projects.• Developed and implemented work instructions for both inspection methods and manufacturing processes.• Designed test and inspection methods using Solidworks and AutoCAD.• Performed scheduled internal audits (ISO 13485 Certified Internal Auditor). Show less

Worked in a team to design electrical components for weapons launch consoles that are used in Naval Submarines.