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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 approximately16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

Job Overview:

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.

Responsibilities:

• Serve as theQuality representativeon cross-functional teams for CDx development projects.

• Collaborate with external and internal partners to defineproduct requirements,intended use, andclinical performance criteria.

• Ensure compliance withdesign control processesper FDA 21 CFR Part 820, ISO 13485, and IVDR.

• Leadrisk management activities(ISO 14971), including hazard analysis, FMEA, and risk mitigation strategies.

• Supportverification and validation (V&V)planning and execution, including analytical and clinical performance studies.

• Review and approvedesign documentation, including DHF elements, specifications, and test protocols.

• Lead and coordinate supplier qualification, incoming inspection, and quality oversight of critical components.

• Driveroot cause analysisandCAPAfor design-related issues during development and transfer.

• Supportregulatory submissions(e.g., PMA, 510(k), CE marking) with quality documentation and technical input.

• Contribute tocontinuous improvementof NPD quality processes and tools

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).

• Minimum 5 years of experience inQuality Engineeringwithin theIVD or medical device industry.

• Strong knowledge ofdesign control,risk management, andregulatory standards(FDA, ISO, IVDR).

• Experience incompanion diagnostics,flow cytometry orclinical assays, preferred.

• Proven ability to work incross-functional teamsand manageexternal 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. There are many factors, such as location, that contribute to the range displayed. 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.

$124,700.00 - $205,800.00 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 sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visithttps://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

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At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salaryor hourly rateranges 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. There are many factors, such as location, that contribute to the range displayed.The salaryor hourly rateoffered to a successful candidate is based on experience, education, skills, andany step rate pay system of the actualwork location, as applicable to the role or position.Salaryor hourly payranges may varyfor Field-based and Remote roles.

Salary Range Information