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Manufacturing Engineering Manager

BD · USA CA - Milpitas 155

Full-timeOn-sitePosted 4 August 2026
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Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. 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 DescriptionThe Manufacturing Engineering Manager is the site-level manufacturing engineering leader responsible for manufacturing process execution, production technical support, equipment readiness, tooling, fixtures, test support, and operational performance for complex instrumentation manufacturing. This role leads the manufacturing engineering team supporting day-to-day operations, process improvement, manufacturing readiness, cost reduction, automation, and technical issue resolution while ensuring compliance with quality, regulatory, and safety requirements. Key Responsibilities Manufacturing Engineering Leadership Lead, manage, and develop the site manufacturing engineering organization supporting production, equipment, tooling, fixtures, process documentation, and technical issue resolution. Establish clear priorities, goals, performance expectations, and resource plans aligned with site operations and business objectives. Build manufacturing engineering capability, technical depth, and succession plans to support current and future business needs. Foster a culture of accountability, safety, compliance, continuous improvement, collaboration, urgency, and high technical standards. Manufacturing & Operations Support Partner with Operations leadership to achieve safety, quality, delivery, cost, productivity, and capacity targets. Support manufacturing throughput, first pass yield, cycle time reduction, labor efficiency, capacity utilization, and product reliability initiatives. Ensure engineering support is available for day-to-day production, system and subassembly testing, troubleshooting, line-down recovery, and issue resolution. Lead or support capital equipment justification, selection, qualification, commissioning, and implementation to improve productivity, capacity, safety, or replace obsolete assets. Develop and maintain manufacturing documentation including work instructions, routings, process specifications, PFMEAs, control plans, validation documents, and equipment procedures. Manufacturing Engineering & Cost Reduction Drive disciplined problem-solving using root cause analysis, Lean, Six Sigma, and continuous improvement methodologies to resolve manufacturing and product performance issues. Manufacturing Readiness, NPI & Technology Transfer Support Partner with R&D, NPI Engineering, Operations, and Quality to support successful transfer of new or changed products into manufacturing. Ensure manufacturing readiness for assigned projects, including processes, tooling, fixtures, equipment, documentation, test support, training, and operational handoff. Provide manufacturing engineering input to design reviews, process readiness reviews, pilot builds, validation planning, and production ramp activities. Support integration of acquisitions, product transfers, or new technologies into site manufacturing operations as required. Supplier & Supply Chain Engineering Support Provide manufacturing engineering support for supplier selection, qualification, manufacturability reviews, and ongoing supplier performance improvement. Partner with Supply Chain and Quality to address supplier quality issues, material constraints, production disruptions, and corrective actions. Ensure critical features, inspection points, process controls, and test requirements are defined and embedded in manufacturing and QC processes. Technical Standards, Systems & Documentation Maintain ownership of manufacturing engineering documentation, production process standards, equipment procedures, tooling records, and other technical manufacturing documents. Ensure compliance with engineering standards, change control requirements, validation practices, and documentation procedures. Develop and apply site-specific manufacturing engineering frameworks and best practices aligned with global standards. Quality, Regulatory & Safety Compliance Ensure manufacturing engineering activities comply with applicable quality systems, regulatory requirements, and internal procedures. Provide technical support for audits, inspections, CAPAs, investigations, and regulatory inquiries related to manufacturing processes and equipment. Ensure adherence to EH&S requirements and promote a strong safety culture across manufacturing engineering activities. Support design control, change management, validation, and risk management processes as they apply to manufacturing operations. Financial & Operational Management Develop and manage manufacturing engineering resource plans, project priorities, operating budgets, and capital requests in alignment with site objectives. Provide cost estimates, run-rate analysis, ROI justification, and input to annual operating and strategic planning processes. Track and report manufacturing engineering performance metrics, project status, and cost improvement results to Operations and site leadership. Qualifications and Experience: Required Bachelor’s degree in Engineering or a related technical discipline. 7+ years of progressive manufacturing engineering experience in a manufacturing environment. 3+ years of people management experience leading engineers, technicians, or technical personnel. Strong experience supporting electro-mechanical instrumentation, complex manufacturing systems, or regulated manufacturing operations. Demonstrated experience improving manufacturing processes, equipment, tooling, fixtures, assembly operations, test processes, and production support systems. Experience leading capital equipment projects from business case development through implementation, qualification, and operational handoff. Demonstrated ability to lead root cause investigations using structured problem-solving tools including 8D, DMAIC, 5 Why, Fishbone Analysis, and A3 methodologies. Strong understanding of process validation, PFMEA, control plans, risk management, and equipment qualification methodologies. Experience with ERP systems, MES systems, and manufacturing data analytics. Excellent communication, leadership, project management, and problem-solving skills. Preferred Master’s degree, MBA, or advanced technical degree. PMP, Lean Six Sigma Green Belt, or Lean Six Sigma Black Belt certification. Hands-on experience implementing manufacturing automation, robotics, machine vision, semi-automated assembly systems, or Industry 4.0 technologies. Experience working with SAP ECC 6 and/or S4/HANA Proficiency in SolidWorks Why Join Us?To f

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