Project Engineer - Equipment & Industrialization

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.