LSD for Equipment Lifecycle ATLAS Remediation Work Stream;ELC Process Steward;Mentor Engineers in proper requirement documentation and verification techniques.

Mentor Mechanical Engineers within Lean Product Design and Design for Manufacturability.Answer mechanical engineering technical questions from internal and external customers.Identify and Implement Technical and Process Improvements to accelerate mechanical engineering work order throughput.

Subject Matter Expert on FDA 820.70 Design Controls. Facilitated improvements within the organization’s Product Development Process. Led Design Verification enhancement team. Changed the internal team from engineering service to engineering peer. Expanded automation and CADD tool utilization and technology. Attended phase and technical review board meetings for various business unit projects. Developed leaders within the organization. Remained hands-on in outsourced capital equipment design, integration, and validation.

Supervised internal equipment group consisting of Mechanical Engineers, Electrical Engineers, Drafters and Technicians. Maintained hands-on development within group. Created and led strategy for Test, Equipment, and CADD resources based on business metrics. Led a cross-functional team in the development and release of Equipment Control Documentation used in the development, testing, and manufacturing of medical devices. Helped develop leaders within the organization. Added metrics in the tracking of time to highlight the false unperceived value of the internal service organization. Shifted a central vulnerable CADD function into an embedded essential need. Lead bi-monthly technology forums for engineers to share knowledge of new techniques and technologies. Attend phase and technical review board meetings for various business unit projects.

Design, Manufacture, and Maintain production floor equipment. Develop process and documentation requirements for production floor equipment. Investigate, Prototype, and Introduce new manufacturing technologies to the company.

Design and Manufacture custom-built machines. Responsibilities include: managing co-workers, managing projects, writing proposals, developing new design concepts, interacting with customers/vendors, budget planning and developing and managing controls to improve quality and increase output of the firm.

Designed, Manufactured, Tested, Verified, Wrote Procedures and Implemented new tooling used on to the production floor which fit within FDA regulations.