Becton Dickinson

Becton Dickinson

Design Quality Engineer III

USA CA - San Diego Bldg A&B, USA · Mid

Sponsorship not specified$106k-$169kDetected 105 days ago
FDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingRegulatory Affairs

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odds of building a lasting career here

52Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role70
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.

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About the role

  • Act as the Quality core team member for sustaining engineering projects.
  • Author field issue assessments using post-market data, complaint investigations, and risk analyses in compliance with 21 CFR 806 and EU MDR.
  • Participate in internal and external audits (e.g., FDA, Notified Body).

Responsibilities

  • Participate in design control activities, including design reviews, risk management, and verification and validation planning and execution.
  • Support the development and maintenance of design and development files (DDFs) to ensure compliance with internal procedures and external regulations (e.g., FDA, ISO 13485).
  • Mentor junior quality engineers and provide technical guidance on design quality principles and practices.
  • Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met.
  • Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.
  • Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness (VOE) to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.

Requirements

  • Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or related field)
  • Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485
  • Hands-on experience with design controls and risk management (ISO 14971)
  • Strong analytical and problem-solving skills with the ability to investigate complex issues
  • Ability to work both independently and collaboratively in a fast-paced environment
  • You can learn more on our career site under " Our Commitment to You."
  • 5-7 years of experience in Design Quality Engineering within the medical device industry
  • Basic understanding of corrections/removals processes (21 CFR Part 806)
  • Effective written and verbal communication skills

Nice to have

  • Master's degree in Engineering
  • Experience with statistical software (e.g., Minitab, JMP)
  • ASQ certification (CQE, CRE, CMQ/OE)
  • 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.
  • At BD, you'll discover a culture in which you can learn, grow and thrive.
  • To learn more about BD visit https://bd.com/careers.
  • Becton, Dickinson, and Company is an Equal Opportunity Employer.

Compensation

  • $105,500.00 - $168,800.00 USD Annual
  • 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

  • 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.

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.