Summary

BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.

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 Engineering or Scientific field, 2 years’ experience including either industry or industry/education Required

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%

Requirements

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 Engineering or Scientific field, 2 years’ experience including either industry or industry/education Required
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%

Benefits

401(k) Matching
Medical, Dental & Vision
Unlimited PTO

Company overview

BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.