Director of Assay Development and Consumables Integration - Handheld Systems

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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 consumables 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.

Key Responsibilities:


* 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...