<p>Description</p> <p>Position Summary</p> <p>The IVD Diagnostic Development Manager leads the design, development, optimization, and lifecycle management of antimicrobial susceptibility testing (AST) diagnostic assays and reagents within a regulated environment. The role drives innovation in assays and biomolecule development, supports product and method advancement through biological sample management, and ensures robust analytical verification and validation to meet regulatory requirements. This position also provides technical expertise for sustaining and improving existing diagnostic products while identifying and integrating emerging technologies and trends in IVD diagnostics.</p> <p>Primary Duties</p> <ul> <li> <p>Builds, leads and oversees a medium-sized team of individual contributors responsible for antimicrobial susceptibility testing (AST) reagent and assay development.</p> </li><li> <p>Manages day-to-day operations of complex laboratory activities, including reagent formulation, assay optimization, and performance characterization within a regulated IVD environment.</p> </li><li> <p>Maintains organizational strategy and AST product development goals relevant to team objectives, technical deliverables, and execution timelines.</p> </li><li> <p>Oversees local budgets, resource planning, and staffing to support development, verification, and support activities.</p> </li><li> <p>Provides technical leadership and training to staff members, while fostering cross-functional collaboration with quality, regulatory, manufacturing, and systems teams.</p> </li><li> <p>Ensures consistent application of quality systems, design controls, and best practices in compliance with FDA, MDR, and internal quality standards.</p> </li><li> <p>Ensure compliance with applicable regulatory requirements (IVDR/MDR).</p> </li><li> <p>Identify and implement operational process optimization and efficiency improvements, including development and application of SOPs and best practices.</p> </li><li> <p>Perform all work in compliance with company quality procedures and standards.</p> </li></ul>