Senior Engineer, Supplier Quality

bdx; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD, a global medical technology leader, seeks a supplier quality/engineering professional in Irvine to lead supplier qualification for NPD, define qualification requirements, and drive inspection method development to assure product quality and regulatory compliance.

You will collaborate with BD plants to optimize receiving inspection and manufacturing processes, while applying Six Sigma and LEAN methods to design for manufacturing and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or Scientific field with 4 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions; OR a Master’s degree in Engineering or Scientific field with 3 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions.
• Experience with supplier/vendor management and qualification activities with new suppliers, CMOs or OEMs for new products.
• Demonstrated experience driving component testing, test method validations, and testing equipment.
• Experience with CAPAs, NCRs, Change Notifications, and/or Auditing.
• Utilizing design tools such as SolidWorks (or other similar design tools).
• Knowledge of FDA and ISO 13485/14971 standards for medical devices is preferred.

Responsibilities

• Be a trusted partner by leading the selection, assessment, and qualification of suppliers for NPD projects including supplier audits to ensure products conform to requirements.
• Drive excellence by defining supplier qualification requirements for components, devices and custom materials for NPD projects to ensure R&D and Manufacturability balance.
• Lead the development, validation, and implementation of inspection and test methods to ensure product quality and regulatory/internal requirements compliance.
• Foster collaboration with BD plants to establish an optimized receiving inspection strategy while promoting inspection at source.
• Lead efforts to optimize complex Manufacturing processes using SIX Sigma and LEAN for design for manufacturing and continuous improvement.
• Build supplier capability and innovation through BD’s supplier excellence initiatives; identify and implement improvements in products and processes at suppliers.
• Build strong supplier relationships through onsite visits, BD’s supplier relationship management programs, supplier forums and other interactions.
• Train, coach, and guide lower-level employees on more complex procedures

Skills

Supplier Quality

Manufacturing

New Product Development/Improvement

Quality Engineering

Education

Bachelor’s degree in Engineering or Scientific field

Master’s degree in Engineering or Scientific field

Tools

SolidWorks

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:

• Be a trusted partner by leading the selection, assessment, and qualification of suppliers for NPD projects including supplier audits to ensure that products received from external suppliers conform to pre-established requirements

• Drive excellence by defining supplier qualification requirements for components, devices and custom materials for NPD projects to ensure the needs from R&D and Manufacturability are balanced

• Lead the development, validation, and implementation of inspection and test methods to ensure product quality and compliance with regulatory and internal requirements.

• Foster collaboration with BD plants to establish an optimized receiving inspection strategy while promoting inspection at source.

• Lead the efforts to ensure optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.

• Build supplier capability and innovation through BD’s supplier excellence initiatives. Identify and implement improvements in products and processes at the suppliers.

• Build strong supplier relationships through onsite visits, BD’s supplier relationship management programs, supplier forums and other interactions.

• Train, coach, and guide lower-level employees on more complex procedures

Required Education & Qualifications:

• Bachelor’s degree in Engineering or Scientific field with 4 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions; OR a Master’s degree in Engineering or Scientific field with 3 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions.

Preferred Qualifications:

• Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.

• Demonstrated experience driving component testing, test method validations, and testing equipment

• Experience with CAPAs, NCRs, Change Notifications, and/or Auditing

• Utilizing design tools such as SolidWorks (or other similar design tools)

• Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices is preferred.

• Ability to work independently without close supervision.

• In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs).

• Demonstrated ability to apply basic statistical quality engineering tools in a manufacturing environment such as Gage R&Rs, control charting, or statistical process controls

• Certified Lead Auditor / ASQ Certified Biomedical Auditor

• Six Sigma Green or Black Belt Certified

• Domestic and International Travel upwards of 25%

Additional Skills:

• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

• Strong problem-solving, organizational, analytical and critical thinking skills

• Good leadership skills and ability to influence change

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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

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 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

$105,500.00 - $168,800.00 USD Annual