Design and develop manufacturing processes for new products and/or changes to existing productsDesign and develop fixtures and tooling for manufacturing processDevelop and execute process validation protocols (IQ/OQ/PQ)Analyze process data and make decisions/recommendations relating to process capability and DFMPerform Installation Qualification (IQ) equipment protocols and reportsCreate and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functionsProvide engineering support to production department in troubleshooting and resolving technical problems.Contact and address component and/or raw material issues with suppliersSupport manufacturing and quality with addressing NCMR issuesPlan, schedule, and complete projects in a manner consistent with business objectivesContribute to the intellectual property position of the company via invention and patent applicationsMaintain accurate documentation of concepts, designs, and processes.Maintain current knowledge of medical, technical, and biomedical developments as related to company products.Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolvedMaintain GMP compliance relating to Document Control, R&D, and Quality AssuranceSupport company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulationsEnsure that all regulatory and internal policies are followedAssist engineering manager in development of engineers providing assistance with coaching and mentoringIdentifies hazards and mitigates risk associated with identified hazards in Process FMEA.

Responsible for the design and development of manufacturing equipment, automation, tooling, and fixtures in support of a next generation AAA device. Collaborate with the Manufacturing, Quality and R&D organization to help facilitate the successful execution of equipment and process design.

Responsible for planing, budgeting, overseeing, and documenting all aspects of assigned projects and works closely with upper management to ensure the scope and direction of each project is on track.

Assist project managers in the successful execution of assigned projects by gathering and reporting data, engaging vendors for updates, and ensuring that project time frames are being met. Responsible for providing administrative support through interfacing with internal departments when necessary to maintain optimal efficiency.

Responsible for gathering and analyzing technical data and relaying information onto Project Coordinators and Project Managers in support of project execution. This role assists the Project Manager in identifying and assuring technical compliance in all items proposed and delivered to the customer. The Technical Monitor is also responsible for identifying and proposing the best possible solution to meet all project requirements and guidelines.

Worked closely alongside process engineers and production managers to design, model, and qualify fixtures for use in testing and manufacturing of laparoscopic surgical devices. Create and revise manufacturing and quality instructions for production teams.

Worked closely alongside process engineers and production managers to design, model, and qualify fixtures for use in testing and manufacturing of laparoscopic surgical devices. Create and revise manufacturing and quality instructions for production teams.

Worked with transgenic mice, conducted dissections, ran PCR to genotype animals in hopes to understand how key genes regulate organ system growth and patterning.

Tasked to receive, diagnose, repair and test Phillips telemetry transmitters. Helped quality control team verify functionality of outgoing units when needed.

Created, executed and revised test protocols, test reports, process validations, product qualifications and design verifications. Constructed SolidWorks parts and assemblies, as well as their corresponding mechanical drawings.