Staff NPI Manufacturing Engineer

Job Responsibility : Lead manufacturing and supply chain design transfer for new flow instruments, subsystems, software-enabled workflows, reagents, and related consumables from feasibility through production release. Represent Operations and Supply Chain in cross-functional core teams; translate application, customer, and manufacturing needs into clear product, system, software, serviceability, and manufacturability requirements. Own factory NPI deliverables and integrated execution plans, including supply chain feasibility and planning, build readiness reviews, pre-production order reviews, manufacturing readiness reviews, and design transfer reviews. Develop and release robust manufacturing and system-test processes, work instructions, standard work, line or cell layouts, utility and network requirements, market configurations, MBOMs, and DMR/DHR content in accordance with approved specifications. Lead process risk assessment and validation activities, including pFMEA, test method validation, fixture and equipment verification or qualification, and process validation such as IQ, OQ, PQ, and PPQ, as applicable. Design, optimize, and sustain instrument performance and system-level testing, calibration, reagent or chemical preparation and control, and associated shop-floor workflows to improve quality, stability, cycle time, and operating efficiency. Lead prototype and pre-production build support, structured problem solving, issue tracking, root-cause analysis, and corrective actions in close partnership with R&D, Quality, Service, Materials & Planning, Sourcing, and Production. Drive Design for Manufacturing, Assembly, Service, and Test reviews; facilitate SDR and related engineering events; define actionable improvements and ensure timely closure of design and process risks. Develop standard cost models and manufacturing inputs for capital, labor, material, capacity, and resource planning; identify cost, quality, delivery, and capacity risks and recommend mitigation plans. Train and coach production associates and engineering partners, support production ramp and early-life stabilization, transfer knowledge across sites. Provide subject-matter expertise for assigned processes and products, including specialized quality-control or value-assignment processes, while balancing priorities across multiple NPI programs. Contributes towards continuously improving global standard work and application of NPI design transfer of BEC LS products. Qualification : Functional Knowledge ： Requires depth and/or breadth of expertise in own specialized discipline or field. Strong knowledge of design control and quality management systems, particularly design transfer, design change, production and process control and purchasing control, preferably life-science, medical-device, or IVD products. Hands-on expertise in system and instrument performance testing, calibration, test-method development and validation, fixture or equipment qualification, and manufacturing process validation. Working knowledge of flow cytometry applications, reagent or chemical handling, software-enabled manufacturing workflows, and data-driven acceptance testing is strongly preferred. Proficiency in DFx, pFMEA, root-cause analysis, statistical methods, Lean manufacturing, Six Sigma or variation reduction, and structured problem-solving tools. Business Expertise: Interprets internal/external business challenges and recommends best practices to improve products, processes or services Understands how product requirements, regulatory expectations, supply chain decisions, factory capability, cost, quality, delivery, and capacity interact across the product lifecycle. Applies project-management practices to scope, schedule, resources, dependencies, risk, cost modeling, and capital planning; converts business challenges into practical execution plans. Leadership: May lead functional teams or projects with moderate resource requirements, risk, and/or complexity. Leads