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Staff NPI Process Quality Engineer

BD -
San Diego, CA

Apply Now

Job Details

$129,600 - $207,400 a year
2 days ago

Qualifications

ISO standards
Quality assurance experience within IT
Quality risk management
Design controls
Biomedical regulatory compliance
Regulatory compliance analysis
Cross-functional communication

Full Job Description

Now

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

Apply Now

Refine Your Search

quality process engineer jobs in san diego, ca

Staff NPI Process Quality Engineer

Senior Manufacturing Engineer – Solid State Power Pulse Modules (SSPPM)

Associate Business Process Automation Engineer

Materials, Process, and Test Engineer

Process Engineer - Chemical

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