Manufacturing Engineer
Katalyst HealthCares & Life Sciences
Manufacturing Engineer
The Manufacturing Engineer will be responsible for developing, validating, and launching manufacturing processes for a large-scale greenfield manufacturing facility. This role supports the end-to-end industrialization journey from early process planning through equipment installation, commissioning, production ramp-up, and operational handovers. The role focuses on translating products, process, quality, safety, capacity, and business requirements into capable, repeatable, scalable, and efficient manufacturing systems. The ideal candidate will combine strong manufacturing engineering fundamentals, hands-on shop-floor experience, and cross-functional leadership to support large-scale factory launch and ramp-up.
Roles & Responsibilities:
- Lead manufacturing process development from concept planning through production launch and ramp-up.
- Define production line requirements, workstation concepts, tooling and fixture needs, equipment interfaces, labor assumptions, process flows, and manufacturing documentation.
- Develop and maintain work instructions, SOPs, process flow diagrams, routings, standardized work, cycle time studies, production checks, and launch readiness checklists.
- Partner with Product Engineering, Operations, Quality, Equipment Engineering, Controls Engineering, Industrial Engineering, Layout Engineering, Supply Chain, Facilities, Construction, EHS, and Maintenance teams to integrate manufacturing requirements into the overall plant design.
- Provide manufacturing inputs to factory master planning, including line layout, equipment placement, operator movement, material presentation, utility needs, ergonomics, safety, maintainability, and scalability.
- Participate in design reviews and provide DFM/DFA feedback to improve manufacturability, assembly efficiency, serviceability, quality, and cost.
- Define workstation-level requirements, including assembly sequence, operator interface, torque strategy, fastening methods, error-proofing, gauges, lifting devices, tools, jigs, fixtures, and production aids.
- Support PFMEA, control plans, APQP/PPAP inputs, process validation, production trials, process audits, run-at-rate, launch readiness reviews, and production handover activities.
- Lead station readiness, tooling readiness, equipment readiness, client readiness, material readiness, process documentation readiness, and quality readiness for new production lines.
- Collaborate with Layout and Industrial Engineering teams to optimize line balance, operator movement, station design, material presentation, line-side storage, capacity, and production flow.
- Work with Equipment and Controls Engineering teams to ensure equipment, fixtures, automation, sensors, HMI, safety systems, and process controls meet manufacturing requirements.
- Support PFEP integration into manufacturing processes, including packaging strategy, sequencing, replenishment, point-of-use storage, line-side delivery, warehouse interfaces, and internal logistics.
- Support equipment installation, commissioning, debug, process validation, run-at-rate, ramp-up stabilization, and transition to stable operations.
- Analyze production performance using OEE, cycle time, downtime, yield, scrap, rework, labor utilization, first-time quality, defect trends, and throughput data.
- Lead root-cause analysis and corrective actions for issues related to process capability, line stoppages, quality defects, rework, scrap, ergonomics, equipment interaction, material flow, or operator efficiency.
- Drive continuous improvement and cost reduction initiatives using lean manufacturing, Kaizen, 5S, VSM, SMED, Poka-Yoke, standardized work, waste elimination, and structured problem-solving methods.
- Evaluate supplier manufacturing feasibility and provide technical inputs for outsourced parts, tooling, fixtures, equipment, and production readiness as required.
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