GIE - EDE Engineer

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 Cap Ex 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,…