GIE - EDE Staff Engineer

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 DescriptionResponsibilities: Product Design / R&D Teams: Ensure products are designed to enable efficient, scalable, and compliant manufacturing processes meeting cost, quality, and regulatory objectives. Manufacturing & Operations Teams: Ensure integrated equipment and processes are operable, reliable, maintainable, and capable of meeting production targets from handover through steady-state operations. Quality & Regulatory Teams: Ensure compliance with validation strategies, GMP, ISO, FDA, and internal quality system requirements. Maintenance & Engineering Teams: Ensure long-term equipment reliability, center lining strategies, spare parts management, and maintenance readiness. Program & Project Management: Ensure alignment on scope, cost, schedule, risk, and delivery milestones. Procurement, Suppliers, and Vendors: Drive supplier technical alignment, capability development, and delivery performance. Finance: Support CapEx planning, forecasting, and reporting. EHS Teams: Ensure machine safety, ergonomics, environmental compliance, and risk mitigation. RESPONSIBILITIES: 1. Process & Equipment Strategy, Design and Development Provide technical ownership and strategic direction for assembly, packaging, automation, inspection, molding, press, and manufacturing equipment. Translate business, product, quality, and capacity requirements into robust end-to-end equipment and automation strategies. Define, create, review, and approve User Requirement Specifications (URS) ensuring clear translation to supplier designs and site needs. Lead the development and evaluation of multiple technical concepts, architectures, and solutions considering risk, scalability, standardization, lifecycle cost, and validation impact. Develop innovative mechanical and automation concepts aligned with BD standards, industry best practices, and emerging technologies. Review and approve mechanical, electrical, and controls architectures, layouts, 3D models, 2D drawings, and system interfaces. Provide expert oversight of engineering analyses and simulations (stress, strain, thermal, airflow, cycle time) to validate and optimize designs. Lead and approve design reviews, machine safety reviews, risk assessments, and FMEA activities. Support and lead Proof of Concept (POC) activities and Design of Experiments (DOE) to define process windows and establish baseline performance. Verify and approve relationships between KPIVs and KPOVs and ensure process capability is demonstrated. Optimize equipment and process designs to improve performance, reliability, ergonomics, changeover time, maintainability, manufacturability, and total cost of ownership. Provide authoritative technical and cost input to capital justification (CB-2) including risk, validation effort, and sustainability of performance. 2. Supplier, Vendor & Capital Program Leadership Act as technical lead for supplier and system integrator engagement on large or complex capital programs. Lead and approve vendor selection, RFQs, and technical evaluations in partnership with Procurement. Define and control supplier technical scope, interfaces, cost, lead time, risks, and performance expectations. Review and approve supplier designs, specifications, safety concepts, automation architecture, and documentation. Lead, witness, and approve Factory Acceptance Tests (FAT) including acceptance criteria, deviation management, and corrective actions. Oversee supplier issue resolution, design changes, and continuous improvement actions. Support contract execution, change management, and claims resolution with Procurement and Legal. Establish and maintain strong long-term technical relationships with strategic equipment suppliers. 3. Equipment Integration, Validation & Start-Up Provide technical leadership for end-to-end equipment integration into operating manufacturing environments. Approve and oversee installation, integration, and commissioning strategies including site readiness, utilities, layout, logistics, and EHS compliance. Lead and approve SAT, commissioning, qualification, and validation strategies. Ensure execution of equipment qualification, process verification, and process validation in compliance with regulatory and quality requirements. Approve validation protocols, reports, and acceptance decisions. Lead and support vertical start-up ensuring equipment, process, documentation, materials, and personnel readiness. Act as escalation point for complex integration, automation, and performance issues. 4. Ramp-Up, Performance & Continuous Improvement Ensure achievement and sustainability of OEE, yield, throughput, scrap, reliability, and capacity targets during ramp-up and early production. Lead and approve center lining strategies to stabilize and optimize long-term equipment performance. Oversee performance gap analysis between expected and actual results and drive corrective action plans. Champion Continuous Improvement (CI) initiatives leveraging Lean Manufacturing, data analytics, and standardization. Drive lessons learned, best practices, and technology reuse across sites and programs. 5. Documentation, Training & Handover Ensure completeness and quality of all equipment and validation documentation, including URS, specifications, drawings, FAT/SAT reports, qualification/validation records, maintenance and control plans, spare parts lists, and software backups. Approve operating instructions, troubleshooting guides, standard work, and maintenance procedures. Ensure site training and capability transfer is completed prior to handover. Approve formal handover to Operations, Maintenance, Engineering, and Quality functions. 6. Compliance, Safety & Quality Leadership Ensure full compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements. Act as technical authority during audits, inspections, and regulatory interactions related to equipment and processes. Promote and model a strong safety, quality, and compliance culture across all projects. 7. Technical Leadership & Mentoring Serve as a senior technical authority and subject matter expert within GIE EDI. Mentor and develop engineers across levels, providing technical guidance and coaching. Lead complex technical discussions and decision-making across global, cross-functional teams. Drive global standardization, harmonization, and knowledge sharing initiatives. Required Qualifications: Bachelor’s Degree in Engineering (Mechanical, Electrical, Controls, Automation, Manufacturing, or related field), or equivalent experience. 8 years of progressively responsible experience in equipment design, automation, manufacturing engineering, and capital project delivery. Extensive experience integrating equipment in complex, regulated manufacturing environments with strong focus on validation and vertical start-up. Proven leadership in large or complex capital projects. Demonstrated expertise in Lean Manufacturing, DOE, SPC, FMEA, and structured problem solving. Willingness and ability to travel internationally as required by project needs. Preferred Qualifications: Experience in an FDA regulated quality environment desired. Knowledge and Skills: Strong ability to synthesize data, risks, and technical information into clear recommendations. Recognized technical authority in manufacturing equipment and automation systems. Strong capital program and stakeholder management capabilities. Exceptional analytical, problem-solving, communication, an