Project Engineer - Equipment & Industrialization

Description du poste

* Medical Devices sector * Development, industrialization and transfer of manufacturing processes. ## About Our Client ## Our client is an established company operating in the **Medical Devices sector**, based in the Lausanne area. ## Job Description ## * Lead industrialization projects from manufacturing process development through to production transfer, ensuring **quality, cost and timeline objectives** are met. * Act as **Work Package Leader** within larger projects, managing planning, timelines, costs and deliverables. * Design, develop and commission **manufacturing equipment, tooling, fixtures, test benches and automated systems**, from mechanical concept through to implementation. * Develop **3D CAD models, technical drawings, tolerance analyses and technical documentation**. * Define and industrialize complete manufacturing workflows, including raw material preparation, cleaning systems, equipment and material flows. * Collaborate closely with **R&D, Product Development, Manufacturing, Quality and Maintenance** to ensure product designs are compatible with manufacturing processes. * Define **User Requirements Specifications (URS)** and contribute to equipment and process specifications. * Support the validation of manufacturing processes and equipment, including **EQ, OQ and PQ activities**. * Prepare and review technical documentation, including **SOPs, batch records, risk assessments, study protocols and technical reports**. * Ensure a robust and compliant **Design Transfer to Manufacturing**, including production documentation, training and support during the first production batches. * Participate in **technology transfer and industrialization projects** towards global manufacturing sites, ensuring scalability, reproducibility and regulatory compliance. * Participate in **equipment and process risk assessments (eFMEA / pFMEA)** and define appropriate mitigation actions. * Identify and implement **continuous improvement opportunities** across manufacturing processes, equipment and automation. * Act as a **Subject Matter Expert** for equipment design, process industrialization and technology transfer, providing technical support and mentoring to other engineers. ## The Successful Applicant ## * Master's degree or equivalent in **Mechanical Engineering, Industrial Engineering or a related engineering discipline**. * **5+ years of relevant experience** in process development, industrialization, equipment engineering, scale-up, validation or technology transfer, ideally within **Medical Devices or Pharmaceutical environments**. * Proven experience working in a **GMP and/or ISO 13485 regulated environment**. * Strong project engineering experience, with the ability to manage technical work packages and deliver projects within **cost, quality and timeline constraints**. * Strong mechanical design skills and hands-on experience with **3D CAD software** such as SolidWorks, CATIA or Inventor. * Experience with **automation, robotics, industrial vision or automated manufacturing systems** is a strong advantage. * Good understanding of manufacturing process development, equipment qualification and process validation. * Structured, hands-on and results-oriented approach, with strong problem-solving and communication skills. * Comfortable working cross-functionally with **R&D, Manufacturing, Quality and external suppliers**. * Fluent in **French and English**, both written and spoken. ## What's on Offer ## * The opportunity to join an innovative **Medical Devices environment** and contribute directly to the industrialization of new products and manufacturing technologies. * A highly technical and cross-functional role combining **project engineering, mechanical design, industrialization and process development**. * The opportunity to work on projects with a direct impact on manufacturing performance and production capabilities. * A dynamic environment offering exposure to **new technologies, automation and advanced manufacturing solutions**. * 1 day of home-office per week. * Flexible working hours. Quote job ref JN-082026-7086989 Job Function Engineering & Manufacturing Specialisation Process Engineering Industry Healthcare / Pharmaceutical Where Lausanne Region Contract Type Permanent Job Reference JN-082026-7086989 Job Nature Home Office