Senior Process Engineer
Department: Operations
Employment Type: Full Time
Location: EMEA-Switzerland-HQ
Description
This position is ideal for mid to senior-level engineering professionals to join the Global Engineering team as a Senior Process Engineer, driving global process standardization and supporting the implementation of scalable manufacturing solutions across Align Technology’s global clear aligner production network.
Partnering with cross-functional teams including Manufacturing, Automatization & NPI engineering, Quality, Regulatory Affairs, and the Software development team, you will act as a key link between global operations and engineering functions. You will support the definition, harmonization, and deployment of global processes, take ownership over the Engineering Change (ECR/ECO) processes, KPI transparency, and operational excellence.
This role is critical in ensuring consistent, compliant, and efficient manufacturing processes across all sites and plays a key part in enabling scalable growth and long-term operational success.
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
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