Michael Love

Owned the development and validation of manufacturing processes for automated suture attaching and in-line testing equipment, leveraging data analysis to solve complex production problems and ensure process control. Spearheaded the technology transfer and initial setup of NPI and legacy production lines to the Costa Rica facility, establishing a robust and scalable foundation for international manufacturing operations. Led process development for critical NPI projects, designing and developing scalable manufacturing processes from the ground up while authoring and executing comprehensive validation protocols (IQ/OQ/PQ) compliant with FDA QSR and ISO 13485 standards. Led the implementation of a phase-gate process for the acquisition and validation of new technological equipment, providing critical recommendations to leadership that improved manufacturing capabilities. Designed and developed production fixtures using SolidWorks and 3D printing, departing from traditional approaches to enhance process stability and reduce operator error. Lead Manufacturing Engineer for NPI projects with our largest customer, contributing expertise in Engineering for Manufacturing early in the design process and launching several new product lines out of our Costa Rica facility. Contributed direct engineering feedback during internal and customer facing cadaver labs to evaluate product effectiveness and influence the iterative design process.

Developed and implemented new process controls and revised procedures for a critical sensor coating and testing process, resolving complex production variables to increase first-pass yield by over 30%. Directed a specialized Six Sigma project to redesign testing protocols, conducting a comprehensive measurement systems analysis (MSA) to eliminate root causes of scrap and achieve a greater than 50% increase in production throughput. Developed and implemented Statistical Process Control (SPC) systems and KPI dashboards to monitor critical process variables, providing actionable data that drove continuous improvement and ensured process stability. Directed cross-functional process improvement projects that reduced material waste and increased overall production throughput.

Conducted routine and non-routine wet chemistry and mercury analysis to ensure materials met strict quality and compliance standards. Managed daily laboratory logistics, including the precise preparation of chemical solutions and the procurement and organization of essential supplies to ensure operational readiness. Played a key role in the planning and construction of a new laboratory facility, contributing to workflow design, equipment layout, and operational readiness planning. Ensured the validity and integrity of analytical results by rigorously adhering to quality control protocols, including the analysis of blanks, duplicates, and control standards as mandated by ISO 17025.

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