Terumo · 1 day ago
Manufacturing Execution System (MES) Engineer - Level 3
Lakewood, CO
Full-time
Hybrid
Mid, Senior Level
$109K/yr - $136K/yr
5+ years expTerumo Blood and Cell Technologies is a leader in medical devices and related products, impacting patients' lives globally. The Manufacturing Execution System (MES) Engineer - Level 3 will focus on the deployment and continuous improvement of MES within a GMP-regulated environment, driving product lifecycle excellence through data analytics and digital transformation.
Health CareManufacturingMedicalMedical DeviceTraining
Responsibilities
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
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
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
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 (eBR) 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 functions to meet commitments
Qualification
Required
Bachelor of Science in Engineering (Industrial, Mechanical, Electrical, Chemical, Systems or related). Equivalent education/experience considered
5 years of experience in a manufacturing environment; medical device or life sciences preferred
Experience with MES validation (IQ/OQ/PQ)
Minimum 2 years under GMP in a regulated environment
Hands-on experience implementing and/or owning MES (e.g., Siemens Opcenter, Critical Manufacturing, SAP, Tulip, Rockwell Automation Plex)
Basic scripting or low-code development (e.g., Mendix, Tulip connectors)
Demonstrated technical innovation, leadership, and strong problem-solving abilities
Process/manufacturing engineering fundamentals; value stream mapping; DFx; SPC
Lean Six Sigma methods; project management; cross-functional influence
Data engineering and analytics; dashboarding/reporting tools; statistical methods and machine learning
Knowledge of FDA regulations, ISO 13485, and validation practices; ability to implement regulatory requirements as necessary
Knowledge integrating MES with ERP (SAP), PLM, SCADA/automation; understanding of ISA-95 models and shop-floor connectivity
Preferred
MES platform certifications (e.g., Siemens Opcenter/Mendix, Critical Manufacturing, Tulip, Plex) are a plus
MES/MOM Certificate is preferred
Benefits
Multiple group medical, dental and vision plans
A robust wellness program
Life insurance and disability coverages
A variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more
401(k) plan with a matching contribution
Vacation and sick time programs for associates
Company
Terumo
Terumo develops technology and medical devices for hollow fiber technology, blood management systems, and endovascular therapy.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$22.95M2016-06-22Grant· $17.4M
2010-12-16Series Unknown· $2.14M
2010-02-26Series Unknown· $3.41M
Recent News
2025-12-10
2025-12-08
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