Principal Engineer, Supplier Quality

Becton Dickinson; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD in Irvine is seeking a senior supplier quality engineer to lead qualification, auditing, and development with a strong emphasis on regulatory compliance and process improvement. You will shape supplier quality strategies for components and materials across NPD programs.

You will drive CAPA, risk management, and advanced measurement methodologies, mentoring engineers and collaborating with cross‑functional teams to meet quality and business objectives.

Qualifications

• Experience leading supplier qualification and quality initiatives.
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971 in medical devices.
• Proven ability to mentor engineers and drive cross‑functional projects.

Responsibilities

• Lead supplier qualification and auditing for NPD projects.
• Define qualification strategies for components and materials.
• Drive continuous improvement via Lean and Six Sigma.
• Lead failure investigations and root cause analysis.
• Develop inspection and test methods to ensure regulatory compliance.

Skills

Supplier qualification

Supplier quality management

Supplier development

CAPA/NCRs

Risk management

FDA regulations

ISO 13485/14971

Six Sigma

SPC / Gage R&R

Leadership / cross-functional

Education

Bachelor’s degree in engineering or scientific field

Master’s degree in engineering or scientific field

Ph.D. in engineering or scientific field

Tools

Gage R&R

SPC

DOE

Control charts

Process validation

IQ/OQ/PQ validation

Medical device QA systems

Job description

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

Job Responsibilities: Serve as a trusted partner by leading the selection, assessment, qualification, and auditing of suppliers for NPD projects, ensuring externally supplied products consistently meet established quality, regulatory, and business requirements. Drive supplier quality excellence by defining qualification strategies and requirements for components, devices, and custom materials, balancing R&D needs with manufacturability and scalability considerations. Build supplier capability by identifying and implementing product and process improvements at supplier sites, establishing robust quality systems, strengthening manufacturing process controls, and driving operational excellence. Lead the development, validation, and implementation of inspection and test methods to ensure product quality, regulatory compliance, and adherence to internal standards. Conduct and lead failure investigations related to field complaints, nonconformances, and manufacturing yield issues, driving effective root cause analysis and corrective actions. Collaborate with BD manufacturing sites to establish optimized receiving inspection strategies while advancing inspection-at-source and supplier quality ownership. Lead initiatives to optimize complex manufacturing processes through engineering and continuous improvement methodologies, including Lean and Six Sigma, to support Design for Manufacturability (DFM) and operational excellence. Build and maintain strategic supplier relationships through onsite assessments, supplier relationship management programs, supplier forums, and ongoing engagement. Mentor, train, and coach team members and junior engineers on advanced quality engineering practices, complex problem-solving, and supplier quality processes.

Required Education & Qualifications

Bachelor’s degree in engineering or Scientific field, 6 years’ experience including either industry or industry/education. Required Master's degree or equivalent in Engineering or Scientific field, 5 years’ experience including either industry or industry/education. Required Ph.D. or equivalent in in Engineering or Scientific field, 2 years’ experience including either industry or industry/education.

Preferred Qualifications

Extensive experience leading supplier qualification, supplier quality management, and supplier development initiatives with global suppliers, CMOs, and OEMs supporting NPD and product lifecycle programs. Recognized expertise in component qualification, reliability testing, test method validation, and advanced measurement systems. Demonstrated leadership in CAPAs, NCRs, supplier corrective actions, change management, risk management, and supplier audits. Advanced knowledge of FDA regulations, ISO 13485, ISO 14971, and medical device supplier controls. Proven experience establishing robust supplier quality systems and capable manufacturing processes, including process validation, SPC, process capability analysis, and continuous improvement. Expert understanding of risk-based validation strategies for equipment and manufacturing processes, including IQ/OQ/PQ and process validation. Advanced proficiency in statistical quality engineering tools, including Gage R&R, SPC, DOE, control charts, and sampling plans. Strong ability to influence cross‑functional teams and supplier leadership, drive strategic initiatives, mentor engineers, and lead complex technical challenges independently. Certified Lead Auditor / ASQ. Certified Biomedical Auditor. Six Sigma Green or Black Belt. Certified Domestic and International Travel upwards of 25%.

At BD, we prioritize on‑site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast‑paced healthcare industry.

For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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 - Irvine Laguna Canyon. 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

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real‑life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

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.