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Terumo Blood and Cell Technologies · 4 days ago

Manufacturing Execution System (MES) Engineer - Level 3

Lakewood, CO

Full-time

Hybrid

Mid, Senior Level

$109K/yr - $136K/yr

5+ years exp

Terumo Blood and Cell Technologies is a global leader in medical devices and related products, dedicated to impacting patient lives through innovative technologies. The MES Engineer will focus on deploying and optimizing manufacturing execution systems to enhance product lifecycle excellence and ensure compliance in a regulated environment.

Medical Device

H1B Sponsor Likely

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

Manufacturing Execution Systems (MES)GMP complianceData engineeringLean Six SigmaStatistical methodsFDA regulationsSAP integrationProject managementBasic scriptingTechnical innovationCross-functional influenceValue stream mappingDashboarding toolsMES platform certificationsProblem-solving

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

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

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

Robust wellness program

Life insurance and disability coverages

Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance

401(k) plan with a matching contribution

Vacation and sick time programs for associates

Company

Terumo Blood and Cell Technologies

Glassdoor3.4

Headquartered in Lakewood, Colorado, Terumo Blood and Cell Technologies is a global leader in blood component, therapeutic apheresis and cellular technologies serving customers in more than 150 countries.

Founded in 1964

Lakewood, Colorado, US

5001-10000 employees

http://www.terumobct.com

H1B Sponsorship

Terumo Blood and Cell Technologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (14)

2024 (7)

2023 (8)

2022 (8)

2021 (8)

2020 (7)