GIE - EDE Engineer 3

Responsibilities

• Product Design Team: Ensure product is designed to enable a mfg. process which can produce product efficiently (target COGS) and to required quality standards.
• Unit Quality Team: Ensure that equip. is designed/manufactured in compliance with regulatory requirements/industry standards.
• Production Team: 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: 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: Ensure that components meet standards/safety and can be sourced timely/cost-effective.
• Plant Quality Team: Ensure that equip. is operating within specified tolerances and products meet required quality & regulatory standards.
• Program Management Team: Ensure that project meets specified requirements that equipment is delivered on time within budget.
• Finance team: Support CapEx planning, forecasting, and reporting.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 regulatory interactions related to equipment and process changes.
• Promote and demonstrate a strong safety, quality, and compliance culture across all project phases.
• Leadership, Mentoring & Collaboration: Provide technical guidance, coaching, and informal mentoring to engineers and cross-functional project team members.
• Lead technical discussions and decision-making across global, cross-functional teams.
• Support global standardization, harmonization, and knowledge sharing across GIE and BD manufacturing sites.

  Requirements

  • Bachelor’s Degree in Mechanical Engineering, Controls Engineering or related field, or relevant equivalent experience.
  • 3+ years in automation / procurement and assembly and packaging experience.
  • Willingness and ability to travel domestically and internationally up to 25%.

  Preferred Qualifications

  • Experience in SolidWorks or other 3d modeling software.
  • Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts.
  • Experience in an FDA regulated quality environment.