MES Engineer III

Joulé

Denver, CO

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JOB DETAILS
SKILLS
Automation Systems, Biology, Code of Federal Regulations, Continuous Improvement, Data Management, ERP (Enterprise Resource Planning), Electricity, Electronic Design, FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Industrial Engineering, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing Execution Systems (MES), Manufacturing Systems, Medical Equipment, Outsourcing, Patient Care, Performance Metrics, Process Flow, Process Validation, Product Lifecycle, Product Lifecycle Management, Productivity Management, Reporting Dashboards, Risk Management, SAP ECC (fka SAP R/3 and SAP ERP), Service Delivery, Technical Support
LOCATION
Denver, CO
POSTED
1 day ago
Job Title: MES Engineer III
Location: Lakewood, CO
Type: Direct Hire
Salary: $100,000-$135,000/year, 7% bonus
Schedule: Monday - Friday Day Hours

Overview:
A global medical device company is seeking an experienced MES Engineer to lead and support the MES enablement process at the site level. This is an impactful opportunity to work 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


Requirements:

  • 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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#LI-GS




Ref: #558-Scientific


About the Company

J

Joulé

With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:

  • Scientific staffing for hard-to-find skills

Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.

  • Clinical lifecycle recruiting

From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.

  • Equipment calibration, maintenance and validation

Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.

  • National healthcare recruitment

Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/