Innovative Health LLC
Scottsdale, AZ
The R&D Advanced Therapeutics Manager role is responsible for leading the development of advanced medical device reprocessing platforms, including Class III devices and complex electromechanical systems. This role provides both strategic and hands-on leadership across advanced therapeutic device reverse engineering and process development, with a focus on system-level architecture, disassembly/reassembly processes, component replacement strategies, and validation of functional equivalence. Essential Duties and Responsibilities: Strategic & Technical Leadership Define system-level architecture across different therapeutics platforms. Establish engineering requirements framework in compliance with FDA, ISO, and internal design controls. Define electrical performance criteria, functional equivalence requirements, and acceptance criteria for reprocessed devices. Lead cross-platform engineering strategy to ensure reuse of validation frameworks. Advanced Reprocessing...