On behalf of our client, we are recruiting for the position of Senior Process Engineer (M/K).
Role summary
This position is ideal for mid to senior-level engineering professionals to join the Global Engineering team of our client as a Senior Process Engineer. The role focuses on driving global process standardization and supporting the implementation of scalable manufacturing solutions across a global production network.
Partnering with cross-functional teams including Manufacturing, Automation & NPI Engineering, Quality, Regulatory Affairs, and Software Development, 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 of 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 execution
* Run and support global cross‑functional meetings (e.g. ECO forums, standardization reviews)
* Define, document, and maintain global standard operating procedures (SOPs), process flows, and best practices
* Collaborate with 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 aligned with standardization goals
* Analyze existing processes to identify inefficiencies, manual effort, and automation opportunities
* Ensure compliance with global and local regulatory requirements (e.g. GMP, ISO 13485, MDR/FDA)
* Support BOM, routing, and system‑related process alignment across SAP, MES, and PLM systems
* Drive continuous improvement initiatives across sites
Skills, Knowledge & Expertise
* Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, or related field
* Minimum 4+ years of experience in manufacturing/process engineering within a regulated industry (e.g. medical device, pharmaceutical)
* Strong understanding of manufacturing processes, documentation, and standardization approaches
* Experience with Engineering Change processes (ECR/ECO)
* Knowledge of GMP and quality systems; familiarity with ISO 13485, MDR, FDA is an advantage
* Experience with systems such as SAP, MES, PLM (e.g. Arena) and system integration across ERP–MES–PLM landscape
* Experience with project/workflow tools (e.g. Asana)
* KPI tracking and reporting experience (Power BI is a plus)
* Strong communication and stakeholder management skills in a global environment
* Ability to work independently and within a matrix organization
* Proactive, structured, and solution‑oriented mindset
Nice to have
* Knowledge of Industry 4.0, digital manufacturing, or automation
* Lean Six Sigma certification (Green Belt or higher preferred)
* Experience in global manufacturing environments
* Additional language skills (e.g. Spanish or Chinese)
* Experience driving large‑scale process improvement and standardization programs
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