Manufacturing Systems/MES Engineer – Product Lifecycle Excellence; PLX
Listed on 2026-02-03
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Engineering
Manufacturing Engineer, Systems Engineer, Quality Engineering
Overview
Global Company is seeking an experience MES Engineer to lead and support the MES enablement process at the site level. This is an impactful opportunity working on technologies and systems that touch and improve patients' lives each day.
Responsibilities- Own and support MES deployment, configuration, governance, training, and continuous improvement at the site level
- Design and optimize electronic work instructions, process flows, dashboards, KPIs, and data pipelines across MES, ERP, and related systems
- Lead Digital Ops Excellence (DOX), Lean, and Six Sigma initiatives to improve yield, cycle time, quality, and compliance
- Define data architecture and apply advanced analytics to support manufacturing and design-for-manufacture decisions
- Ensure GMP compliance, audit readiness, validation activities, and risk mitigation across manufacturing systems
- Bachelor of Science in Engineering (Industrial, Mechanical, Electrical, Chemical, Systems, or related)
- Minimum 5 years of experience in a manufacturing environment (medical device or life sciences preferred)
- At least 2 years working under GMP in a regulated environment
- Hands-on experience implementing, validating, and/or owning Manufacturing Execution Systems (MES)
- Experience with MES validation (IQ/OQ/PQ)
- Knowledge of FDA regulations, ISO 13485, and 21 CFR Part 820
- Experience integrating MES with ERP systems (SAP preferred), PLM, and shop-floor automation systems
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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