Innovative Health LLC

The Senior R&D Engineer role is responsible for designing, developing, validating, and implementing various methods and processes, leading and assisting in projects to introduce new products into production. This role is expected to bring unique perspectives and creative solutions to challenges faced during reverse engineering and reprocessing technique development. Essential Duties and Responsibilities: • Assist and/or lead in development of new medical device platforms complying with design control process including applicable FDA and ISO requirements. • Develop, write, and execute test methods. • Train manufacturing/QC personnel as needed on test methods or manufacturing processes. • Generate formal test protocols and reports. • Execute test protocols and conduct bench testing. Document test results per GDP, ISO, and FDA requirements. • Coordinate and oversee test sample builds. Assist with test sample builds as required. • Use Solidworks to design test fixtures and...

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...

The Sr. Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrations to regulatory agencies. Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product. Responsible for preparing Canadian applications to obtain approval to commercially distribute product. Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information. Prepare routine regulatory correspondence and assure submission to government agencies in support of marketed products. Participate in project development teams and review plans, reports, risk management, and design reviews associated with product and process projects. Assess necessity for submitting a 510(k) application by preparing...