Manufacturing Execution System; MES Engineer – Level 3

Requisition  Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

This role combines process/manufacturing engineering with digital transformation and analytics to drive Product Lifecycle Excellence (PLX) across a GMP-regulated manufacturing environment. The engineer will help during site deployment, ownership, and continuous improvement of Manufacturing Execution Systems (MES) while building/modeling data pipelines, dashboards, and digitalization that improve quality, throughput, and compliance (e.g., eDHR/e ). The position requires hands‑on shop‑floor engagement, cross‑functional leadership, and strong problem solving to deliver measurable business outcomes.

MES Deployment, Ownership, and Governance:

• Support deployment, integration, configuration, and roadmap of the MES platform(s); act as the primary site owner/SME for MES usage, training, documentation, and troubleshooting.
• Design and optimize process flows, electronic work instructions, and conditional routing to streamline manufacturing, assembly, and test operations.
• Develop and maintain core dashboards, KPIs, and reports; enable teams to self‑serve analytics and data visualization for day‑to‑day execution.
• Build automations/connectors and data pipelines to extend MES functionality and integrate with ERP (SAP), PLM, CMMS, and LMS.

Process Improvement & Product Lifecycle Excellence:

• Evaluate current‑state processes and product lifecycle workflows; map value streams and identify waste and bottlenecks.
• Lead Digital Ops Excellence (DOX) projects using Lean or Six Sigma to improve yield, cycle time, and first‑pass quality while maintaining regulatory compliance.
• Standardize and document best practices; facilitate workshops and training to embed improvements and ensure adoption.

Data Architecture & Advanced Analytics:

• Define data architecture and standardized methods for collection, processing, and storage of manufacturing data (data lake/warehouse concepts).
• Deploy statistical analyses, machine learning, and modeling to evaluate large data sets and support design‑for‑manufacture and process optimization decisions.
• Communicate insights and trends to stakeholders; deliver updates and recommendations that connect analytics to business outcomes.
• Champion data quality, governance, and traceability across MES, ERP, PLM, LIMS, and IIoT sources.

Compliance, Quality, and

Risk Management:

• Implement and adhere to GMP practices, ISO 13485, and FDA regulations (e.g., 21 CFR Part 820); support validations (IQ/OQ/PQ) and audit readiness.
• Leverage MES capabilities such as electronic Device History Records (eDHR) and electronic Batch Records (e ) to enforce production processes and capture complete as‑built records.
• Identify risks, develop mitigation plans, and execute tasks to avoid serious delays and unplanned expenditures.

• Engage frequently with stakeholders across engineering, supply chain, quality, operations, and external partners; represent the organization on complex technical topics.
• Present technical information clearly to technical staff and management; influence cross‑functional teams and mentor junior engineers/technicians.
• Provide work direction and ensure alignment with key leaders; collaborate within Innovation & Development (I&D) or similar…