Staff NPI Process Quality Engineer

Skip to main contentWe use cookies and other tracking technologies to assist with navigation, improve our products and services, assist with our marketing efforts, and provide content from third parties. By continuing to use this site you agree to our use of cookies in accordance with our privacy policy. Manage third-party cookie preferences hereDeclineAccept CookiesEnglishSign InStaff NPI Process Quality Engineer page is loadedStaff NPI Process Quality EngineerApplyremote typeIn-OfficelocationsUSA CA - San Diego (BDB)time typeFull timeposted onPosted 19 Days Agojob requisition idR-547724As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job DescriptionSummary: We are seeking a highly motivated and detail-oriented New Product Development (NPD) Quality Engineer to join our team. This role is embedded within a cross-functional core team and plays a critical part in both ensuring compliance and driving efficiency in the design and development lifecycle. The primary focus of this position is to streamline and optimize design control processes to support the efficient and compliant development of In Vitro Diagnostic (IVD) products, including Research Use Only (RUO), IVD-CE marked, and clinical diagnostic products intended for global markets. The successful candidate will bring hands-on experience as a Quality Engineer supporting product development, along with a demonstrated ability to improve and scale quality processes. The role spans reagent systems, complex instrumentation, and software/informatics platforms across both New Product Introduction (NPI) and sustaining activities. This individual will collaborate closely with R&D, Regulatory Affairs, and Operations to implement right-sized, risk-based design control frameworks that balance agility for RUO products with regulatory rigor for clinical and IVD-labeled products.  Responsibilities: Serve as the Quality representative on cross-functional teams for continuous improvement of NPD quality processes and tools. Collaborate with external and internal partners to define product requirements, intended use, and clinical performance criteria. Ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR. Support risk management activities (ISO 14971), including hazard analysis, FMEA, and risk mitigation strategies. Support verification and validation (V&V) planning and execution, including analytical and clinical performance studies. Review and approve design documentation, including DHF elements, specifications, and test...