Teams at Lexington Medical

Own and improve the Arena electronic Quality Management System, ensuring compliance with ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR. Manage document control, CAPA, nonconformance, training, audits, supplier quality, risk management, metrics, and computer system validation. Prepare the organization for certification and regulatory audits while partnering with Operations, Engineering, Regulatory, and Manufacturing to drive quality improvements.

Leads a team of mechanical and product engineers developing surgical stapling instruments from concept through production and sustaining changes. Owns design controls, Design History Files, design transfer, technical project execution, design reviews, root cause analysis, and cross-functional collaboration with manufacturing, quality, regulatory, supply chain, and commercial teams. Manages hiring, development, performance, project planning, and delivery for regulated medical device products.

Develop, test, and debug embedded firmware for surgical stapling devices using C and C++ on ARM Cortex-M microcontrollers. Build drivers, communication interfaces, motor-control logic, and sensor integrations. Collaborate with electrical, mechanical, and systems engineers during hardware bring-up and bench debugging. Support verification, validation, code reviews, and documentation compliant with FDA design controls and IEC 62304.