Project Engineer - Equipment & Industrialization

Reporting to the Process Development & Industrialization organization, you will be responsible for the development, industrialization and transfer of manufacturing processes and equipment, from initial concept through to implementation in production.

Our client is an established company operating in the Medical Devices sector, based in the Lausanne area.

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.

Profile

• 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.

Job 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.