Senior Process Engineer

Role summary

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

Complementary skills

• 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