Project Engineer - Equipment & Industrialization
Lausanne
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.
- 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.
- 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.
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