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.
Department: Operations
Location: EMEA-Switzerland-HQ
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
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Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
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