Becton Dickinson

Becton Dickinson

Staff NPI Process Quality Engineer

USA CA - San Diego (BDB), USA · Staff+

Sponsorship not specified$130k-$207kDetected 105 days ago
Data EngineeringProduct ManagementProcess ImprovementFDA RegulatoryFlow CytometryMedical DevicesResearchCommunicationCollaborationProblem SolvingLean ManufacturingRegulatory Affairs

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odds of building a lasting career here

56Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role70
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

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About the role

  • We are seeking a highly motivated and detail-oriented New Product Development (NPD) Quality Engineer to join our team.
  • 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.

Responsibilities

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

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • Experience work ing in cross-functional teams and managing external partnerships utilizing e xcellent communication, documentation, and problem-solving skills.
  • At BD, you'll discover a culture in which you can learn, grow and thrive.

Nice to have

  • Preferred Skills/Knowledge:

Skills

  • Master's degree in Engineering, Life Sciences
  • E xperience in Software quality assurance
  • ASQ certification in Lean Six Sigma G reen B elt /B lack B elt
  • Experience in flow cytometry instruments and/or clinical assays.

Compensation

  • $129,600.00 - $207,400.00 USD Annual
  • 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.
  • 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.

Benefits

  • Minimum 5 years of experience in Quality Engineering within the IVD or medical device industry.
  • Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service.
  • 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.

Company info

  • We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world.
  • Job Description Summary: We are seeking a highly motivated and detail-oriented New Product Development (NPD) Quality Engineer to join our team.

Visa & Work Authorization

  • 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 orientatio
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This listing is sourced directly from Becton Dickinson's careers page and normalized into a canonical job model.