System One · 14 hours ago
Manufacturing Systems / MES Engineer – Product Lifecycle Excellence (PLX)
Lakewood, CO
Contract
Onsite
Senior Level
$100K/yr - $135K/yr
5+ years expSystem One is a global company seeking an experienced MES Engineer to lead and support the MES enablement process at the site level. This role involves deploying and optimizing manufacturing execution systems to improve processes and ensure compliance within a regulated environment.
Staffing Agency
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
Qualification
Required
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
Benefits
Medical
Dental
Vision
Spending accounts
Life insurance
Voluntary plans
Participation in a 401(k) plan
Company
System One
System One is a professional staffing firms.
5001-10000 employees
H1B Sponsorship
System One 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 (5)
2024 (6)
2023 (9)
2022 (10)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
$301.8MKey Investors
TruistOaktree Capital ManagementProspect Capital Corporation
2021-01-28Debt Financing· $290M
2020-12-08Private Equity
2016-09-20Acquired
Leadership Team
Troy Gregory
Chief Executive Officer
Dan Moran
Chief Financial Officer
Recent News
2026-01-06
Company data provided by crunchbase