Nobel Biocare · 9 hours ago
MES Operations Engineer
Yorba Linda, CA
Full-time
Onsite
Mid Level
$83K/yr - $118K/yr
3+ years expNobel Biocare is a company focused on manufacturing solutions, and they are seeking a MES Operations Engineer to analyze and support various manufacturing applications. The role involves collaborating with multiple departments to ensure MES implementations enhance efficiency, quality, and compliance across manufacturing lines.
DentalHealth DiagnosticsManufacturing
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
Qualification
Required
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
Benefits
Annual performance bonus
Medical/dental/vision benefits
401K match
Company
Nobel Biocare
Nobel Biocare is a company that manufactures dental implants and CAD/CAM-based individualized prosthetics. It is a sub-organization of Danaher.
1001-5000 employees
H1B Sponsorship
Nobel Biocare 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 (3)
2024 (1)
2023 (2)
2022 (3)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2014-09-15Acquired
Leadership Team
Ashley Keim, MA
Senior Human Resources Business Partner, Commercial Team
Dulce Ortega, MSW
Sr. HR Business Partner
Recent News
2025-10-25
Company data provided by crunchbase