Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Clinical Science, Biomedical Science, Engineering or related scientific discipline. Advanced degree (MSc or PhD) desirable.
• Experience developing in-vitro diagnostic assays, clinical laboratory tests or regulated analytical products. Experience applying ISO 14971 risk management principles within medical device or IVD development. Knowledge of IVD regulatory requirements including IVDR and FDA expectations.
• Understanding of assay development processes including reagent development, calibration strategies, quality controls and analytical performance evaluation. Understanding of assay verification and validation methodologies.
• Experience facilitating risk analyses such as Hazard Analysis, DFMEA, PFMEA and Fault Tree Analysis.
• Experience working within a multidisciplinary product development environment.
• Well-developed analytical and problem-solving skills, with the ability to understand complex clinical workflows and assay processes.
• Effective facilitation skills for risk reviews and cross-functional workshops.
• Excellent technical writing and documentation skills, with attention to detail and the ability to maintain risk and traceability information accurately and effectively.
• Ability to explore assumptions thoughtfully and contribute to evidence-based decision-making. Excellent verbal and written communication skills.
• Ability to work collaboratively across multidisciplinary and geographically distributed teams.
• Commitment to continuous learning and the ability to apply evolving regulatory and industry best practices.
• Some international travel may be required.

You may not meet every requirement listed above, and that's okay. If you are excited by the opportunity to contribute to the development of innovative clinical diagnostic solutions and believe your experience is relevant, we encourage you to apply. We value diverse experiences, perspectives, and backgrounds, and recognise that great candidates often bring transferable skills gained through a variety of career paths.

In addition to salary, we work flexibly and provide 25 days holidays, excellent family friendly benefits such as attractive employer pension contribution, life assurance, income protection and private medical. With Waters, there are plenty of opportunities for you to grow, develop and contribute.

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, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate 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. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.