NPD Quality Engineer

Job Description Summary

As 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 seeking a highly motivated and detail-oriented NPD Quality Engineer to join our Companion Diagnostics (CDx) team. This role will be embedded within a cross‑functional core team, collaborating closely with pharmaceutical partners to design, develop, and validate IVD companion diagnostics aligned with targeted drug therapies. The ideal candidate will bring expertise in IVD product development, design control, and regulatory compliance, with a strong understanding of clinical and research workflows.

• Serve as the Quality representative on cross‑functional teams for CDx development projects.
• 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.
• Lead 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 protocols.
• Lead and coordinate supplier qualification, incoming inspection, and quality oversight of critical components.
• Drive root cause analysis and CAPA for design‑related issues during development and transfer.
• Support regulatory submissions (e.g., PMA, 510(k), CE marking) with quality documentation and technical input.
• Contribute to continuous improvement of NPD quality processes and tools.

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
• Minimum 5 years of experience in Quality Engineering within the IVD or medical device industry.
• Strong knowledge of design control, risk management, and regulatory standards (FDA, ISO, IVDR).
• Experience in companion diagnostics, flow cytometry or clinical assays, preferred.
• Proven ability to work in cross‑functional teams and manage external partnerships.
• Excellent communication, documentation, and problem‑solving skills.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field‑based and Remote roles.

$ - $ USD Annual

At BD, we prioritize on‑site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast‑paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of…