Principal Engineer, Supplier Quality
BDNow 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 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…