Leadership

Employed since 2019

Education: PhD in Bioanalytical Chemistry from Florida International University.

Previous experience: More than 15 years of scientific and leadership experience in diagnostic and medical device industry. Lucy has been at Boule for more than 6 years working with cross functional teams resulting in successful launch of new hematology consumables achieved under compliance to ISO 13485 and FDA regulatory frameworks, and implementation of IVDR Class A documentation for existing products.

Prior to joining Boule, she worked at Davita Laboratories, the 25^th largest laboratory in Unites States where she held multiple positions within R&D and production settings focusing on water quality analysis for dialysis patients and development and validation of robust and novel chemistry assays using both atomic and molecular mass spectrometry.

Employed since 2000

Education: Master of Science from Queen’s University Belfast (N. Ireland); Master of Business Administration from Florida Atlantic University (USA).

Previous experience: Mike brings over four decades of experience in clinical diagnostics, spanning R&D leadership, project management, quality, manufacturing, and strategic business development. He spent 17 years at Beckman Coulter within the Coulter Diagnostics Division, where he led cross-functional R&D initiatives in collaboration with engineering and manufacturing teams, ultimately serving as Senior Scientist and Project Manager. Since joining Clinical Diagnostics Solutions/Boule Medical in 2000, he has managed R&D, QC, and manufacturing functions and has been instrumental in driving Business-to-Business partnerships. Mike currently serves as Senior Vice President of Business Development. Born in Northern Ireland, he has lived in the USA, Jamaica, Wales, and Bermuda, bringing a broad international perspective to his leadership.

Employed since May 2010

Education: Master of Accounting in Forensic Accounting, Florida Atlantic University.

Previous Experience: Karlene has been a valued member of Boule US for over 16 years, advancing through roles as Inventory Clerk, Accountant, Accounting Manager and now Senior Accounting Manager. In the role of Senior Accounting Manager, Karlene leads the accounting team and oversees financial reporting, budgeting, internal controls, compliance, and financial operations.

Employed since 2021

Education: Studies in Human Resources Management and Business Administration, with advanced expertise in organizational development, compliance, and talent management.

Previous Experience: More than 20 years of Human Resources leadership experience within pharmaceutical, biomedical, medical device, and clinical diagnostics organizations. Proven expertise in building and scaling HR functions, talent acquisition, employee engagement, compensation and benefits, organizational development, and regulatory compliance. Extensive experience supporting FDA audits, ISO 13485 quality standards, and multi-state workforce operations. Fluent in English and Spanish.

Employed since 2017

Education: Master of Science in Applied Statistics from ITESM Campus Monterrey (Mexico), Bachelor of Science in Physics from ITESM Campus Monterrey (Mexico)

Previous experience: 25+ years of progressive leadership across automotive, industrial, electronic, and medical device sectors. Credentialed in the Danaher Business System (DBS) at Danaher, and certified Six Sigma Master Black belt by the American Supplier Institute at Thomson Televisiones de Mexico.

Employed since July 2018

Education: Doctor of Philosophy in Chemistry, University of Warwick (UK)

Previous experience: More than 18 years of experience in medical device R&D, spanning cardiovascular technologies to hematology and diagnostic solutions. Progressed through technical and scientific leadership roles, building expertise in product development, technology transfer, regulatory support, and  global commercialization.