Siemens Opcenter Architect

Overview

Define and design MES architecture using Siemens Opcenter. Ensure scalability, reliability, and security of MES solutions. Implementation, configuration, and support of Siemens Opcenter Medical Suite within medical device manufacturing environments. Design and configure manufacturing processes, workflows, routings, and work instructions aligned with regulated operations. Implement and maintain electronic Device History Records (eDHR) and Electronic Batch Records (e ). Ensure system compliance with FDA 21 CFR Part 11, ISO 13485, GMP, and GAMP 5 requirements.

Configure and support quality management workflows including NC, deviations, CAPA, and change control. Perform and support system validation activities (IQ/OQ/PQ) and validation documentation. Integrate Opcenter with ERP (SAP/Oracle), PLM (Teamcenter), equipment automation, and third‑party systems. Collaborate with manufacturing, quality, validation, IT, and regulatory stakeholders. Support UAT, user training, and audit readiness activities. Drive continuous improvement initiatives and support multi-site/global Opcenter rollouts.

• Siemens Opcenter Medical Suite (Camstar Medical) – advanced configuration and customization
• Manufacturing Execution Systems (MES) in regulated industries
• Regulatory compliance: 21 CFR Part 11, ISO 13485, GMP, GxP, GAMP 5
• System integration with SAP, Oracle ERP, Teamcenter PLM
• Batch and discrete manufacturing processes (medical devices)

• Paid Leave
• Health Insurance
• Group life insurance
• Disability
• 401(K)
• The expected salary range for this position is between $60,000 to $1,30,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.