Becton, Dickinson and Company

Staff NPI Process Quality Engineer

Becton, Dickinson and Company • $129K — $207K *
San Diego, CA 92154In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 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 experience in design control, risk management, and regulatory standards (FDA, ISO, IVDR, China).
  • Experience working in cross-functional teams and managing external partnerships.
  • Excellent communication, documentation, and problem-solving skills.

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, including hazard analysis, FMEA, and risk mitigation strategies.
  • Support verification and validation 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 with quality documentation and technical input.

Benefits

  • Comprehensive Total Rewards program.
  • Opportunities for reward and recognition in a performance-based culture.
  • Commitment to supporting and developing associates.
  • A competitive package of compensation and benefits programs.
Full 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 experience in design control, risk management, and regulatory standards (FDA, ISO, IVDR, China). 
  • Experience working in cross-functional teams and managing external partnerships utilizing 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. 

Required Skills

Optional Skills

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Primary Work LocationUSA CA - San Diego (BDB) Additional Locations Work ShiftNA (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

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

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Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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