Staff NPI Process Quality Engineer

In-Office, San Diego, CA

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Job ID: R-547724
Category: Engineering
Location: San Diego, California

Construye una carrera en ingeniería donde la innovación, la autonomía y el impacto hacen avanzar la atención médica

En BD, los profesionales de Ingeniería e I+D diseñan, desarrollan y mejoran las tecnologías que dan forma a cómo se entrega la atención médica en todo el mundo. Aplicarás pensamiento científico, experiencia técnica y resolución creativa de problemas para convertir desafíos complejos en soluciones que importan.

Ya sea que te especialices en ingeniería mecánica, eléctrica, de procesos, de sistemas, de software o de investigación, BD ofrece la escala, los recursos y la libertad para innovar, con expectativas claras, responsabilidad por los resultados y oportunidades para hacer crecer tu carrera junto a tecnología líder en la industria.

Y como una de las compañías de tecnología médica más grandes del mundo, darás forma a soluciones que alcanzan sistemas de salud globales y mejoran vidas a gran escala.

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 the people who give possibilities purpose

BD 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 Description

Summary:

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 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), IVD-CE marking, China) with quality documentation and technical input.

Minimum Requirements:

Bachelor’s degree in Engineering, Life Sciences, or related field.

Minimum 5 years of experience in Quality Engineering within the IVD or medical device industry.

Strong experiencein design control, risk management, and regulatory standards (FDA, ISO, IVDR, China).

Experience working in cross-functional teams and managing external partnershipsutilizing excellent communication, documentation, and problem-solving skills.

Preferred Skills/Knowledge:

Master’s degree in Engineering, Life Sciences

Experience in Software quality assurance

ASQ certification in Lean Six Sigma Green Belt/Black Belt

Experience in flow cytometry instruments and/or clinical assays.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://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.

Required Skills

Optional Skills

Primary Work Location

USA CA - San Diego (BDB)

Additional Locations

Work Shift

NA (United States of America)

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$129,600.00 - $207,400.00 USD Annual

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Perfil de Éxito

¿Qué distingue a los profesionales exitosos de Ingeniería e I+D? Es probable que prosperes si eres:

Analítico/a
Colaborativo/a
Curioso/a
Orientado/a al detalle
Inventivo/a
Solucionador/a de problemas

¿Listo/a para tu próximo desafío?

Este es un ambiente para ingenieros que quieren pensar con audacia y ejecutar con precisión. Tendrás la oportunidad de influir en decisiones de diseño, contribuir a lo largo de todo el ciclo de vida del producto y ver cómo tu trabajo pasa del concepto al impacto en el mundo real, respaldado por la escala de un líder global en MedTech.

Escucha a uno de nuestros Innovadores de BD sobre cómo BD utiliza inteligencia artificial y aprendizaje automático de vanguardia para impulsar decisiones que mejoran los resultados de los pacientes y expanden el acceso a la atención médica. Aquí es donde tu trabajo genera impacto en tiempo real en todo el mundo.

Escucha de nuestros asociados

"BD es una compañía grande y global, así que no tengas miedo de conectar y contactar a otros. Hay tanto que aprender aquí, la compañía hace un trabajo increíble ayudando a las personas a desarrollarse y crecer. También recomendaría convertirse como en una esponja y absorber tanto conocimiento como puedas y poner tu Plan de Carrera a trabajar para ti. Realmente amo mi trabajo y estoy muy agradecida de trabajar en BD."

Elaheh Alizadeh

Directora, I+D – San Diego, CA, Estados Unidos
"Creo que tenemos algo así como más de 30 países diferentes representados por quienes trabajan en el Centro de Investigación de Irlanda, lo cual es impresionante y una de mis cosas favoritas sobre BD. Trabajo con ingenieros eléctricos, mecánicos, científicos y muchos otros; es maravilloso ver y escuchar tantas perspectivas diferentes durante el día."

Balaguru Palanivel

Ingeniero/a de Pruebas de Software Staff – Limerick, Irlanda
"Continúo asombrado de cómo seguimos innovando en el espacio de Med Tech. Constantemente evaluamos cómo llevar aún más soluciones a los profesionales de la salud, cómo aumentar la eficiencia de nuestras tecnologías, todo mientras mantenemos en mente el impacto en el paciente. No solo he encontrado trabajo significativo en BD, sino un lugar donde siento que puedo prosperar."

Rob Swanda

Ingeniero Staff – San Diego, CA, Estados Unidos
"Durante mi entrevista, aprendí cuánto impacto tienen nuestras soluciones de infusión en todo el mundo y quedé impresionado porque ya sean analgésicos, tratamientos contra el cáncer, anestesia u otros tratamientos, la probabilidad de que alguien dentro de tu propia familia use nuestro producto es alta. Contribuir a la creación de productos que tienen la capacidad de generar un impacto tan grande en la atención médica es una gran sensación. Amo mi rol en BD."

Simon Bello

Director Senior, I+D – San Diego, CA, Estados Unidos