Job Description
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Varian Medical Systems, a Siemens Healthineers company is looking for a Manufacturing Execution System (MES) Specialist to own, build, and evolve our MES platforming alignment with our fast-growing operations. The MES Specialist will be responsible for implementing, supporting, configuring, and optimizing the Manufacturing Execution System to enable efficient, compliant, and data-driven production operations. This role bridges manufacturing, quality, and IT functions to ensure the MES integrates seamlessly with enterprise systems—including SAP—and satisfies FDA regulatory expectations for medical device manufacturing. This role will drive process digitalization, troubleshoot system issues, support new product introductions, and ensure that electronic device history records (eDHR), traceability, and other regulated manufacturing processes operate with high reliability and integrity. What You Will Do MES Administration & Support Configure, maintain, and troubleshoot MES modules (routings, operations, materials, data collections, non-conformances), workflows, business rules, and user interfaces. Manage master data, recipes, routing, and equipment/asset configuration within MES. Provide day-to-day support to the operations and respond to system issues in a timely manner. Develop and modify electronic work instructions, forms, checklists, and eDHR components. Support system upgrades, patches, and deployment activities with minimal disruption to operations. SAP Integration & Cross-System Expertise Collaborate with SAP functional teams to integrate MES with SAP modules such as production planning, quality management, material management, and warehouse management. Ensure accurate and timely data exchange between MES and SAP (e.g., orders, materials, batch/lot info, results, and confirmations). Test and validate integrations, interface mappings, and data flows. Troubleshoot cross-system issues involving MES–SAP communication or data synchronization. MES Integration of equipment and line automation for real-time operation reporting. Compliance & FDA Regulatory Requirements Ensure MES workflows and data records comply with FDA 21 CFR Part 820, 21 CFR Part 11, ISO13485, and other applicable regulations. Participate in validation activities including IQ/OQ/PQ documentation, risk assessments, and change control. Support audits (internal, external, and FDA inspections) by providing system documentation, training records, and data reports. Assist in maintaining validated state of MES solutions and ensuring electronic record/electronic signature (ERES) compliance. Continuous Improvement & Digital Manufacturing Identify opportunities to optimize production processes through MES enhancements and automation. Partner with lean/industrial engineering teams to streamline workflows and eliminate waste. Support deployment of data analytics, KPIs, dashboards, and real-time shopfloor visualization tools. Participate in cross-functional projects including new product introductions (NPIs), capacity expansions, and system migrations. What You Will Have Bachelor’s degree in Engineering, Information Systems, Computer Science, or related field (or equivalent experience). 3+ years of experience working with MES platforms in a manufacturing environment. 2+ years of experience with SAP (Production Planning, Quality Management, Materials Management, or related modules). Strong understanding of FDA medical device regulations (21 CFR 820, 21 CFR 11) and ISO13485. Excellent skills in SQL server and scripting (preferred). In-depth knowledge of C#.NET or C++ and UI/UX (preferred). Experience with validation, change control, and GxP documentation practices. Ability to translate manufacturing processes & requirements into functional MES workflows. Excellent problem-solving, communication, and cross-functional collaboration skills. #LS-OS1 Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they ar