Manufacturing Execution System (MES) Engineer - Level 3

Terumo BCT•Littleton, CO

5d•$109,100 - $136,400•Hybrid

About The Position

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/eBR). The position requires hands-on shop-floor engagement, cross-functional leadership, and strong problem solving to deliver measurable business outcomes.

Requirements

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.

Nice To Haves

MES platform certifications (e.g., Siemens Opcenter/Mendix, Critical Manufacturing, Tulip, Plex) are a plus.
MES/MOM Certificate is preferred.

Responsibilities

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 (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.
OTHER DUTIES AND RESPONSIBILITIES
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.

Benefits

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

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