Director of Assay Development and Consumables Integration - Handheld Systems

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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 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 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 reliability.
* Define and track key performance indicators (e.g., assay performance metrics, consumable yield/cost, project milestones) to measure the team's effectiveness and product performance.
Use these metrics to drive accountability and continuous improvement in development velocity, product quality, and reliability.

Qualifications:

Education & Experience
* Bachelor's degree in Chemistry, Biochemistry, Biomedical/Chemical Engineering, Engineering or related field; an advanced degree is strongly preferred.
* Minimum of 12 years of progressive experience in the in vitro diagnostics (IVD) or medical device industry.
* Strong experience with electrochemical sensor development, reagent chemistry optimization, and microfluidics is required.
* Experience with high-volume consumable manufacturing processes (e.g.
injection molding, automation equipment).
* Demonstrated success in bringing point-of-care diagnostics products to market.
* Strong working knowledge of design controls and global regulations (FDA QSR, ISO 13485, IVDR, ISO 14971 risk management) is required to effectively manage development within a regulated medical diagnostics environment. Leadership &

Competencies:

* Demonstrated ability to lead…