GIE - EDE Engineer 3

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 Responsibilities: Product Design Team: to ensure product is designed to enable a mfg. process which can produce product efficiently (target COGS) and to required quality standards. Unit Quality Team: to ensure that equip. is designed/manufactured in compliance with regulatory requirements/industry standards. Production Team: to ensure that equipment is designed for efficient production, and to support mfg. process. To ensure that the integrated equipment / processes are easy to operate, maintain, reliable and that equipment is operating efficiently / effectively from handover / hyper care to meet production targets. Maintenance/Engineering Team: to ensure max. equip. uptime, and that equip. is designed for easy maintenance/repair. To ensure that equipment is maintained and serviced according to recommended schedules and procedures. Procurement & Vendors: to ensure that components meet standards/safety and can be sourced timely/cost-effective. Plant Quality Team: to ensure that equip. is operating within specified tolerances and products meet required quality & regulatory standards. Program Management Team: to ensure that project meets specified requirements that equipment is delivered on time within budget. Finance team: Support CapEx planning, forecasting, and reporting. 1. Process & Equipment Design and Development Lead the design and development of assembly, packaging, automation, inspection, and manufacturing equipment, including mechanical, electrical, controls, vision, robotics, and software elements. Translate product, process, quality, and capacity requirements into robust equipment and automation concepts. Define, create, review, and maintain User Requirement Specifications (URS) aligned with manufacturing, quality, regulatory, safety, and business needs. Develop and evaluate multiple technical solutions and concepts, considering risk, robustness, scalability, standardization, cost, and lifecycle impact. Develop innovative concepts for mechanical systems and automation based on project requirements, industry trends, and BD standards. Create, review, or approve 3D models, 2D drawings, layouts, and system architectures generated internally or by suppliers. Perform or review engineering analyses and simulations (e.g., stress, strain, thermal, airflow, cycle time) to validate and optimize designs. Lead and participate in design reviews, risk assessments, machine safety reviews, and FMEA activities to ensure compliance, safety, reliability, and performance. Verify relationships between Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs). Support Proof of Concept (POC) activities and Design of Experiments (DOE) to establish process windows, baselines, and capability metrics. Optimize equipment designs to improve manufacturability, operability, ergonomics, maintainability, changeover time, reliability, and total cost of ownership. Capture, analyze, and leverage process and equipment performance data from existing production lines to inform new designs and improvements. Provide detailed technical and cost input for capital justification activities (e.g., CB-2), including equipment cost, engineering effort, validation scope, risk, and implementation timeline. 2. Supplier & Capital Project Leadership Lead and coordinate external suppliers, system integrators, and equipment vendors throughout the full project lifecycle. Support and lead vendor selection in partnership with Procurement, including RFQs, technical evaluations, supplier capability and risk assessments. Define and manage supplier technical scope, cost, lead time, risks, deliverables, and interfaces. Review and approve supplier designs, specifications, software architecture, electrical and mechanical schematics, and safety concepts. Plan, witness, and approve Factory Acceptance Tests (FAT), including definition of test plans, acceptance criteria, deviation management, and re-tests. Manage supplier corrective actions, technical changes, and continuous improvement actions. Support contract execution, change control, and claims management in collaboration with Procurement and Legal. Establish and maintain strong technical relationships with key equipment manufacturers and technology partners. 3. Equipment Integration, Installation, Validation & Start-Up Drive the end-to-end integration of new equipment and processes into existing manufacturing environments. Prepare and execute detailed equipment installation and integration plans, including site readiness, utilities, layout, logistics, EHS compliance, and resource planning. Coordinate and support Site Acceptance Tests (SAT), commissioning, and handover readiness. Execute and/or support equipment qualification, process verification, and process validation in alignment with Quality and Regulatory requirements. Ensure validation strategies, protocols, and reports are completed, reviewed, and approved. Manage and execute vertical start-up activities, ensuring equipment, process, documentation, materials, and people readiness. Ensure training plans, operating instructions, standard work, and competence assessments are completed prior to formal handover. Ensure minimal disruption to ongoing operations during installation, integration, or software changes. Lead or support troubleshooting, diagnosis, and resolution of equipment, automation, process, or integration issues using structured problem-solving and root cause analysis methodologies. 4. Ramp-Up, Performance Management & Continuous Improvement Provide sustained technical support during production ramp-up to achieve OEE, yield, throughput, scrap, reliability, and capacity targets. Perform and support center lining activities to stabilize and optimize equipment and process performance. Measure, analyze, and track gaps between expected and actual performance during ramp-up and early production. Lead and support corrective actions and recovery plans to close performance gaps and ensure long-term capability. Identify, consolidate, and implement improvement opportunities related to equipment design, integration approach, validation strategy, tools, and methodologies. Support and lead Continuous Improvement (CI) initiatives, including Lean Manufacturing, data-driven optimization, and standardization efforts. 5. Documentation, Training & Handover Ensure creation, completion, review, and formal handover of comprehensive equipment documentation, including URS, specifications, architecture diagrams, FAT/SAT reports, validation documentation, maintenance plans, control plans, spare parts lists, and software backups. Support the documentation of equipment operating instructions, process parameters, standard work, troubleshooting guides, and maintenance procedures. Support and deliver training to site personnel on new equipment, automation systems, and manufacturing processes. Coordinate and execute formal handover to Operations, Maintenance, Engineering, and Quality teams to ensure sustainable steady-state production. 6. Compliance, Safety & Quality Ensure all equipment, installations, and modifications comply with EHS requirements, international standards, and BD policies, including machine safety, LOTO, guarding, controls, and ergonomics. Ensure compliance with GMP, ISO, FDA, and BD Quality System requirements throughout design, integration, validation, ramp-up, and sustained production phases. Support internal and external audits, inspections, and reg