Director of Assay Development and Consumables Integration - Handheld Systems

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. We are seeking a results-driven R&D leader to head our Assay Development & Consumables Integration team within the Handheld Systems organization.

In this critical role, you will spearhead end-to-end development of both assay chemistry and consumable components for our point-of-care handheld blood gas instruments. As a key member of the Handheld R&D leadership team reporting to the VP of R&D, Handheld Systems – you will ensure seamless product integration and robust, system-level performance. The ideal candidate is a seasoned leader with deep expertise in IVD assay development and consumable engineering, a track record of launching complex diagnostic products, and the strategic acumen to drive new innovations while sustaining on-market product excellence.

This role combines scientific innovation with disciplined engineering execution, ensuring that assay performance and consumable design are optimized together to deliver reliable, high-quality diagnostic solutions.

• Manage, mentor, and develop a high-performing, multidisciplinary team of scientists and engineers specializing in assay chemistry and consumable (e.g. test card, collection device) development.
• Foster a culture of scientific rigor, collaboration, and accountability that inspires excellence and continuous improvement.
• Represent the team as a core member of the Handheld Systems R&D leadership to shape product strategy and ensure alignment with business goals.
• Own end-to-end development of next-generation blood gas assays (test menu expansion) and associated consumables (such as test cards, and sample collection devices).
• Establish rigorous product requirements and specifications using sound science, statistical methods, and industry best practices.
• Serve as the primary integrator between assay chemistry and consumable design, ensuring that assays function to requirements within their consumable format and within the overall device system.
• Partner closely with the Systems Development & Integration (SDI) team to achieve seamless hardware-software-assay interoperability and robust system performance.
• Collaborate with the Assay Performance (Lifecycle engineering) team to align on sensor calibration and data analytics, ensuring new assay and consumable designs meet overall system performance requirements.
• Provide technical leadership for sustaining the performance and continuous improvement of on-market assays and consumables.
• Own design changes due to part, material, or reagent obsolescence, ensuring thorough risk assessment, change control, maintenance of product performance and regulatory compliance.
• Oversee the development of robust manufacturing processes and ensure Critical-to-Quality attributes are well controlled in high-volume production - working closely with Manufacturing, Supply Chain, Quality and Regulatory teams to plan for scalable production, manage technical design transfers, and uphold continuous supply.
• Ensure all development and sustaining activities are executed with excellence and strict adherence to global IVD regulatory standards (FDA Quality System Regulations, ISO 13485, IVDR, CLSI, ISO 14971 risk management).
• Maintain comprehensive design history files and risk management documentation for assays and consumables.
• Resolve cross-functional challenges and champion decisions that balance innovation speed with compliance and…