MES Operations Engineer

Envista Holdings Corporation•Yorba Linda, CA

About The Position

The MES Operations Engineer responsible for analyzing and supporting various manufacturing applications, ensuring manufacturing continuity, and facilitating process improvements. They will bridge the gap between IT systems, production operations, and engineering teams to ensure MES implementations enable efficiency, quality, traceability, and compliance across manufacturing lines. This role requires a comprehensive understanding of manufacturing processes and collaboration with multiple departments to deliver high-quality results in a fast-paced manufacturing environment. The position requires hands-on shop-floor engagement, cross-functional leadership, and strong problem solving to deliver measurable business outcomes. The role will also be part of different project initiatives as a project resource.

Requirements

Bachelor of Science in Engineering (Industrial, Mechanical, Electrical, Chemical, Systems or related). Equivalent education/experience considered.
3+ 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).
Lean Six Sigma methods; project management; cross-functional influence.
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
Working knowledge of SAP
Experience in a medical device manufacturing company

Responsibilities

Providing ongoing support and address user inquiries related to internal MES systems
Understanding of how different systems may be interfaced and the flow of data between systems
Keep documentation up to date with any system changes or updates
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.
Work closely with manufacturing engineers to analyze workflows, identify requirements, and translate them into technical specifications.
Design solutions for production tracking, quality management, and inventory control, supporting continuous improvement and lean manufacturing initiatives.
Participate in Kaizens and process improvement activities aligned with the Business Solutions Roadmap
Collaborate with process engineering, quality, IT, supply chain, and manufacturing departments to ensure continuity
Work independently and as part of a team to identify and address issues proactively
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.