Waters Corporation

Systems Engineer - Assay Integration

In short

This Systems Engineer - Assay Integration role at Waters Corporation sits in the Clinical Systems Development team, bridging assay science and analyser engineering to build next-generation clinical LC-MS diagnostic systems. The job owns assay requirements across the product lifecycle, translates clinical and user needs into traceable system requirements, and drives verification and validation with Quality and Regulatory teams. It demands a scientific/engineering degree plus experience in IVD, diagnostics or regulated medical device development, strong systems-thinking and cross-disciplinary collaboration skills, with occasional domestic and international travel.

Overview
Join Waters' Clinical Systems Development team and play a pivotal role in bridging assay and analyser development, to deliver the next generation of clinical LC-MS diagnostic systems. As a Systems Engineer - Assay Integration, you will work with multidisciplinary teams spanning assay science, software, engineering and systems development, ensuring innovative assays are successfully translated into robust, integrated diagnostic solutions. This is a unique opportunity to influence products from early concept through commercialisation while helping deliver technologies that support better clinical decision-making and improve patient outcomes worldwide.
Responsibilities
•Own and manage assay requirements throughout the product lifecycle, ensuring solutions meet customer, clinical and business needs
•Act as the key technical link between Assay Development and Analyser Engineering teams, driving alignment across multidisciplinary stakeholders.
•Define how assays integrate with software, consumables, sample preparation and LC-MS instrumentation to deliver a complete diagnostic solution.
•Translate user needs and analytical performance goals into clear, traceable and verifiable system requirements.
•Support technical decision-making by evaluating design options, system trade-offs and performance requirements across the diagnostic platform.
•Collaborate with Quality, Regulatory and Risk Management teams to ensure compliance with applicable IVD standards.
•Drive successful verification and validation activities, ensuring integrated assay solutions perform as intended and are ready for commercial deployment.
Qualifications
Education:
•Bachelor's degree in Analytical Chemistry, Biochemistry, Clinical Chemistry, Biomedical Science, Engineering, or a related scientific discipline.
Experience:
•Experience within the IVD, diagnostics, life sciences, or regulated medical device industry, with a strong understanding of assay development and product development processes.
Competencies:
•Ability to translate customer, clinical and business needs into clear, traceable technical requirements.
•Strong understanding of clinical assay development, analytical performance and diagnostic workflows.
•Proven ability to work effectively across multidisciplinary teams, influencing and collaborating with scientific, engineering and business stakeholders.
•Strong systems-thinking, problem-solving and communication skills, with the ability to manage complexity and drive technical decisions.
•Passion for developing innovative diagnostic technologies that improve patient care and healthcare outcomes.
Travel (If Applicable):
•Occasional domestic and international travel to support project activities, customer interactions and collaboration with global teams.
Benefits
In addition to salary, Waters offers flexible working, 25 days holidays, and family friendly benefits such as an attractive employer pension contribution, life assurance, income protection and private medical cover.
Company Description
Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, its innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. Waters collaborates with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. The company's passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

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