Project Engineer - Equipment & Industrialization in Lausanne

pulliMedical Devices sector /liliDevelopment, industrialization and transfer of manufacturing processes. /li /ulh3bAbout Our Client /b /h3pOur client is an established company operating in the bMedical Devices sector /b, based in the Lausanne area. /ph3bJob Description /b /h3ulliLead industrialization projects from manufacturing process development through to production transfer, ensuring bquality, cost and timeline objectives /b are met. /liliAct as bWork Package Leader /b within larger projects, managing planning, timelines, costs and deliverables. /liliDesign, develop and commission bmanufacturing equipment, tooling, fixtures, test benches and automated systems /b, from mechanical concept through to implementation. /liliDevelop b3D CAD models, technical drawings, tolerance analyses and technical documentation /b. /liliDefine and industrialize complete manufacturing workflows, including raw material preparation, cleaning systems, equipment and material flows. /liliCollaborate closely with bRD, Product Development, Manufacturing, Quality and Maintenance /b to ensure product designs are compatible with manufacturing processes. /liliDefine bUser Requirements Specifications (URS) /b and contribute to equipment and process specifications. /liliSupport the validation of manufacturing processes and equipment, including bEQ, OQ and PQ activities /b. /liliPrepare and review technical documentation, including bSOPs, batch records, risk assessments, study protocols and technical reports /b. /liliEnsure a robust and compliant bDesign Transfer to Manufacturing /b, including production documentation, training and support during the first production batches. /liliParticipate in btechnology transfer and industrialization projects /b towards global manufacturing sites, ensuring scalability, reproducibility and regulatory compliance. /liliParticipate in bequipment and process risk assessments (eFMEA / pFMEA) /b and define appropriate mitigation actions. /liliIdentify and implement bcontinuous improvement opportunities /b across manufacturing processes, equipment and automation. /liliAct as a bSubject Matter Expert /b for equipment design, process industrialization and technology transfer, providing technical support and mentoring to other engineers. /li /ulh3bThe Successful Applicant /b /h3ulliMaster's degree or equivalent in bMechanical Engineering, Industrial Engineering or a related engineering discipline /b. /lilib5+ years of relevant experience /b in process development, industrialization, equipment engineering, scale-up, validation or technology transfer, ideally within bMedical Devices or Pharmaceutical environments /b. /liliProven experience working in a bGMP and/or ISO 13485 regulated environment /b. /liliStrong project engineering experience, with the ability to manage technical work packages and deliver projects within bcost, quality and timeline constraints /b. /liliStrong mechanical design skills and hands-on experience with b3D CAD software /b such as SolidWorks, CATIA or Inventor. /liliExperience with bautomation, robotics, industrial vision or automated manufacturing systems /b is a strong advantage. /liliGood understanding of manufacturing process development, equipment qualification and process validation. /liliStructured, hands-on and results-oriented approach, with strong problem-solving and communication skills. /liliComfortable working cross-functionally with bRD, Manufacturing, Quality and external suppliers /b. /liliFluent in bFrench and English /b, both written and spoken. /li /ulh3bWhat's on Offer /b /h3ulliThe opportunity to join an innovative bMedical Devices environment /b and contribute directly to the industrialization of new products and manufacturing technologies. /liliA highly technical and cross-functional role combining bproject engineering, mechanical design, industrialization and process development /b. /liliThe opportunity to work on projects with a direct impact on manufacturing performance and production capabilities. /liliA dynamic environment offering exposure to bnew technologies, automation and advanced manufacturing solutions /b. /lili1 day of home-office per week. /liliFlexible working hours. /li /ul /p #J-18808-Ljbffr