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

As a Distinguished Quality Engineer at Becton, Dickinson and Company, you will be a recognized technical leader, driving significant advancements in quality engineering methodologies, strategies, and practices across the organization to ensure the highest standards of product safety, efficacy, and compliance.

Key Responsibilities:

• Provide expert guidance and strategic direction on complex quality engineering challenges throughout the product lifecycle, from concept to post-market surveillance.

• Lead the development, implementation, and continuous improvement of advanced quality systems, processes, and methodologies (e.g., Six Sigma, Lean, Design for Quality, Statistical Process Control).

• Represent the organization as a subject matter expert during regulatory audits and inspections (e.g., FDA, ISO, MDR), effectively communicating compliance strategies and resolutions.

• Develop and implement advanced metrics and KPIs to monitor quality performance, identify trends, and drive continuous improvement initiatives.

• Drive proactive identification and mitigation of quality risks, utilizing sophisticated analytical tools, reliability and statistical techniques

• Evaluate external technologies, intellectual properties, and suppliers for business development opportunities to solve complex problems

• Participate in engineering advisory board (e.g., ISO committee, validation board, industry forums)

• Train, coach, and guide lower level employees on highly complex or novel procedures

• May be selected as an Independent Reviewer for design review

• Lead training, new system procedures, and new method development

• Extensive experience with risk management tools and techniques (e.g., DFR, FMEA, PHA, FTA).

• Proficiency in statistical software (e.g., Minitab, JMP) and advanced statistical analysis.

• Ability to travel domestically and internationally as required.

• Adherence to BD Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Other incidental duties

Education and Experience:

• Bachelor's Degree in Engineering or Scientific field, 12 years experience including either industry or industry/education Required or

• Master's Degree or equivalent in Engineering or Scientific field, 11 Year experience including either industry or industry/education Required or

• Ph.D. or equivalent in Engineering or Scientific field, 8 years experience including either industry or industry/education Required

Additional Skills:

• Quality SME with end-to-end product lifecycle experience from new product develop to post market.

• Engineering expertise design, materials, and processes for complex electro-mechanical systems for hemodynamic monitoring capital equipment and sensors.

• Demonstrated expertise and deep understanding of global medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, MDSAP).

• Ability to translate highly complex and technical information to all levels of the organizations

• Exceptional analytical, problem-solving, and critical thinking skills, demonstrating knowledge on using advanced tools such as (DMAIC, Fault-Tree Analysis, Shainin Red-X, Reliability Modeling and Predictions)

• Proven track record of leading significant quality improvement initiatives and implementing advanced quality methodologies (e.g., Black Belt Six Sigma certification highly desirable).

• Excellent documentation, presentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Strong leadership skills and ability to influence change and challenge status quo with respect to opportunities for improvement

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

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Primary Work Location

USA CA - Irvine Laguna Canyon

Additional Locations

Work Shift

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

$155,900.00 - $257,300.00 USD Annual