Senior Process Engineer

Description

Key Responsibilities

• Support the Global Engineering Director in defining and driving global process standardization initiatives across manufacturing sites
• Act as a key contributor and coordinator for the global Engineering Change (ECR/ECO) process, including governance, improvements, and operational execution
• Run and support global cross-functional meetings (e.g. ECO forums, standardization reviews) to ensure alignment across sites and functions
• Define, document, and maintain global standard operating procedures (SOPs), process flows, and best practices
• Collaborate with site engineering, operations, and quality teams to ensure effective implementation of global processes and standards
• Support KPI definition, tracking, and reporting (e.g. via Power BI), identifying gaps and driving data-based improvements
• Contribute to global engineering and manufacturing projects, ensuring alignment with standardization goals and global strategies
• Analyze existing processes to identify inefficiencies, manual effort, and improvement opportunities, including automation potential
• Ensure compliance with global and local regulatory requirements (e.g. GMP, ISO 13485, MDR/FDA) in all process-related activities
• Support BOM, routing, and system-related process alignment across platforms such as SAP, MES, and PLM systems (e.g. Arena)
• Act as a proactive problem solver and drive continuous improvement initiatives across sites

Skills, Knowledge & Expertise

• Education: Bachelor’s or master’s degree in mechanical engineering, Industrial Engineering, or a related production/science-based field
• Experience: Minimum 4+ years of experience in manufacturing engineering or process engineering within a regulated industry (medical device, pharmaceutical, or similar)
• Process Expertise: Strong understanding of manufacturing processes, process documentation, and standardization approaches
• Change Management: Solid experience with Engineering Change processes (ECR/ECO), including governance and execution
• Regulatory Knowledge: Good understanding of GMP and quality systems; familiarity with ISO 13485, MDR, FDA or similar regulations is a strong plus
• Systems Knowledge: Experience with manufacturing and engineering systems such as SAP, MES, and PLM tools (e.g. Arena), including a strong understanding of system capabilities and data structures; proven experience in driving system implementation, integration, and optimization across functions (e.g. ERP–MES–PLM landscape); experience with project and workflow management tools such as Asana, ideally in implementing and scaling them as global project tracking and dashboard solutions
• Data & Reporting: Experience in KPI tracking and reporting; familiarity with tools such as Power BI is an advantage
• Communication: Strong communication and facilitation skills, with the ability to align cross-functional and international stakeholders
• Teamwork: Ability to work both independently and collaboratively in a global, matrix organization
• Mindset: Proactive, structured, solution-oriented, and self-driven working style

• Knowledge of Industry 4.0, digital manufacturing, or process automation
• Lean Six Sigma certification (Green Belt or higher preferred)
• Experience in global manufacturing environments and cross-site collaboration
• Language skills such as Spanish or Chinese are a plus
• Experience in driving process improvements and standardization programs at scale

• Health and well-being programs to keep you thriving in both body and mind.
• Employee-exclusive discounts on Invisalign products.
• Learning opportunities through online learning resources and support for your individual development plans.
• Inclusive, global workplace that fosters collaboration, recognition and belonging.