Support deployment, integration, configuration, and roadmap of 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 operations
Develop and maintain core dashboards, KPIs, and reports
Enable teams to self-serve analytics and data visualization for day-to-day execution
Evaluate current-state processes and product lifecycle workflows
Lead Digital Ops Excellence (DOX) projects using Lean or Six Sigma
Define data architecture and standardized methods for collection, processing, and storage of manufacturing data
Champion data quality, governance, and traceability across MES, ERP, PLM, and IIoT sources
Implement and adhere to GMP practices, ISO 13485, and FDA regulations

Requirements

Bachelor of Science in Engineering (Industrial, Mechanical, Electrical, Chemical, Systems or related)
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)
Knowledge of FDA regulations, ISO 13485, and validation practices

Benefits

Multiple group medical, dental and vision plans
Robust wellness program
Life insurance and disability coverages
401(k) plan with a matching contribution
Vacation and sick time programs
Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

MES validationGMP practicesLeanSix Sigmadata architecturedata qualitydata governancedata traceabilityscriptinglow-code development

trainingdocumentationtroubleshootingprocess optimizationanalytics enablementproject leadership

Bachelor of Science in EngineeringISO 13485FDA regulations