Responsible for leading new product development, program management, and design transfer of innovative Laser Interstitial Thermal Therapy (LITT) devices through a focus on requirements generation/implementation, design for manufacturability, process capability, and data driven decisions.

Responsible for the engineering leadership and guidance of product and process development activities for active neuromodulation lead devices. Works cross functionally with project management, operations, and design assurance/quality engineering to prioritize project deliverables and ensure timely execution of customer needs.Interfaces directly with customers to develop and implement requirements for product development builds and ensure the integrity of customer needs and specifications.Project and resource management for multiple development and production transfer projects, ensuring on time execution and implementation of deliverables.Implements data driven decisions through the authoring, execution, and analyzation of engineering studies to support design and process specifications.Drives systematic improvements and engagement through the development/implementation of standard operating procedures and organizational policies.

Responsible for the development, characterization, optimization and validation of manufacturing processes for Cardiac Rhythm Management and Neuromodulation leads devices. Collaborate with customers and design team to ensure that all processes and related tooling are capable of meeting internal and external requirements related to the customer needs and related drawings. Identify and qualify manufacturing equipment through the creation of equipment specifications directly related the manufacturing process needs.Provide systematic guidance to engineers and manufacturing operators to ensure all processes and documented builds are being developed and completed in line with all internal regulatory and quality system requirements.

Worked as a Senior Design Assurance Engineer to author and execute the design and development plan to ensure the proper requirements, testing, and documentation were being completed in order to comply with ISO-13485 and 21 CFR 820. Led cross functional groups through remediation efforts to bring existing and new product documentation and quality system records in line with MDR requirements. Created template for Design History Files to ensure the proper retaining of all product related documentation.Helped develop user needs through formative studies and house of quality exercises.Authored and executed accelerated aging, real time aging, and distribution protocols and reports.

Lead team of engineers and techniciansProvide manufacturing quality support, nonconformance management, problem solving, root cause investigation, and solution development/implementation Provide a quality engineering mindset and knowledge to ensure success of cross functional projectsConduct data collection and analyze trends for ongoing monitoring and process/product improvements Support timely execution of deliverables to support business team and functional objectivesAuthor and execute IQ/OQ/PQ protocols and reportsAnalyze proposed manufacturing, design, and supply changes and determine appropriate validation / verification requirements.Review and support DOE activities for process capability Provide guidance and statistical support as necessaryAuthor and execute test/inspection method validation protocols and reports Conduct design validation activities Manage and own cross-functional CAPA projects Interface with Operations and Engineering groups to ensure design transfer of new product/manufacturing site transfers are in accordance within the quality system requirements Support risk management activities Author and execute Master Quality Plans/Reports and Master Validation Protocols/Reports Author and maintain process FMEAs Support new product development Front and back room support for internal and external audits

Support ongoing improvement and corrective action activities. Conduct data collection and analysis/trending for ongoing monitoring and process/product improvements.Support timely execution of deliverables to support business team and functional objectives.Provide internal and external audit support as necessary.Analyze proposed manufacturing, design, and supply changes and determine appropriate revalidation / re-verification requirements.Provide guidance and statistical support as necessary.Provide manufacturing support, including nonconformance management, problem solving, root cause investigations, and solution development/implementation. Interface with Operations and Engineering groups to ensure transfer to production of new products are in accordance with requirements.Support risk management activities.Provide technical assistance for incoming inspection and manufacturing quality problems. Support manufacturing area improvement projects.Review production areas to ensure operating procedures are being followed.

Coordinate the process validation activities for development projects.Author Equipment Requirement Specifications (ERS)Create and execute IQ/OQ/PQ protocols and reportsDesign and evaluate DOEs in order to perform process characterization studiesAuthor PVMP/PVMR, PV Protocols, and PV ReportsEnsure the adequacy of validation documents, the adequacy of the validation methodology used, and that validation documents are written in compliance with current industry standards and regulatory requirements. Execute the validation studies, analyze data, and gain approval on all validation documents.

Provide a quality mindset in the lab and on the production floor Responsible for improving manufacturing process and the quality of product via corrective and preventative action and good manufacturing practicesDetermined cause and source of contamination of returned/out of spec products Tested manufactured product Developed training and specifications for new and current products Authored new lab proceduresQuality inspection of incoming and outgoing product