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 multidisciplinary R&D teams, including talent development and building a culture of scientific excellence, accountability, and innovation. * Strong communication and influencing skills to collaborate with senior stakeholders across R&D, Quality, Regulatory, Manufacturing, Marketing, and external partners. * Proactive and data-driven approach to problem solving and project management.
Able to navigate complex technical challenges, manage ambiguity, and drive effective decision-making with cross-functional input. * Systems thinking approach with a passion for integration - skilled at ensuring diverse technical functions (assay chemistry, consumables engineering, hardware/software) work in concert to produce a cohesive, highly reliable diagnostic system. Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries.
As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing.
Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas.
We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare.
For everyone.
Everywhere.
Sustainably. To find out more about Siemens Healthineers' businesses, please visit our company page at Siemens Healthineers Canada. The expected compensation for this position is: $110,000 - $157,000 Factors which may affect starting compensation within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. Siemens Healthineers offers a variety of health and wellness benefits including a flexible benefits plan, Defined Contribution Pension Plan, Registered Retirement Savings Plan matching contributions, plus a competitive paid time off program including vacation, company holidays, sick leave, and parental leave (all subject to eligibility requirements). This information is provided per required laws and regulations.
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