Stellenbeschreibungh2ABOUT FORTIL /h2pFortil is an international engineering and technology consulting group built on an independent entrepreneurial model. With more than 2,500 employees across 30 offices in 14 countries, Fortil empowers talented professionals to develop their expertise through challenging industrial projects while fostering innovation, autonomy and continuous growth. /phrh1JOB DESCRIPTION /h1pAs part of the expansion of our activities in strongFrench-speaking Switzerland /strong, we are looking for an strongRD Technical Leader – Disposable Kits (M/F). /strong /ppReporting to an Engineering Manager, you will support the development and lifecycle management of innovative disposable products used within the Medical Device and Biopharmaceutical industries. /ppWorking in a highly regulated environment, you will lead sustaining engineering activities, coordinate multidisciplinary stakeholders and ensure the successful implementation of product and process changes throughout the product lifecycle. /ppYour main responsibilities will include: /pullipLead sustaining engineering activities for existing products throughout their lifecycle. /p /lilipDrive engineering change implementation related to products, materials, suppliers and manufacturing processes. /p /lilipAssess technical impacts and risks associated with product modifications. /p /lilipCoordinate verification activities required to support engineering changes. /p /lilipCollaborate closely with Quality, Regulatory Affairs, Manufacturing, Supply Chain and external suppliers. /p /lilipSupport root cause investigations and continuous improvement initiatives. /p /lilipEnsure product quality, compliance and continuity of supply. /p /lilipMaintain technical documentation according to quality management requirements. /p /lilipContribute to technical decision-making while ensuring project execution, planning and stakeholder alignment. /p /li /ulhrh1YOUR PROFILE /h1pYou hold a Master's degree in Mechanical Engineering, Biomedical Engineering, Materials Science or a related discipline and have significant experience within the Medical Device or Life Sciences industry. /ph3Required experience /h3ullip5 to 10 years of experience in Product Development, Sustaining Engineering or Product Lifecycle Management. /p /lilipExperience managing Engineering Change processes. /p /lilipExperience working in regulated environments (Medical Device or Biopharma). /p /lilipExperience collaborating with manufacturing sites and external suppliers. /p /lilipPrevious involvement in multidisciplinary technical projects. /p /lilipExperience supporting product lifecycle activities from development to industrialization. /p /li /ulh3Technical skills /h3ullipProduct Lifecycle Management (PLM) /p /lilipEngineering Change Management /p /lilipRisk Assessment /p /lilipDesign Control principles /p /lilipVerification Validation /p /lilipRoot Cause Analysis /p /lilipContinuous Improvement /p /lilipTechnical Documentation /p /li /ulh3Additional assets /h3ullipExperience with disposable or single-use products. /p /lilipKnowledge of plastics, tubing, injection moulding or medical assemblies. /p /lilipFamiliarity with ISO 13485 requirements. /p /lilipSupplier Quality experience. /p /li /ulh3Languages /h3ullipProfessional English is mandatory. /p /lilipFrench is considered a strong asset. /p /li /ulhrh1WHY JOIN FORTIL? /h1pAt Fortil, we provide a stimulating environment where talented engineers can continuously develop their expertise. /ppWe offer: /pullipContinuous learning and career development. /p /lilipOpportunities to work on cutting-edge international projects. /p /lilipAn entrepreneurial environment encouraging initiative and innovation. /p /lilipThe possibility to become a shareholder within the Group. /p /lilipParticipation in meaningful CSR initiatives. /p /lilipA people-first culture supporting work-life balance and professional growth. /p /li /ulpFortil is committed to equal opportunities. All applications are considered regardless of gender, age, disability, ethnic origin, religion or sexual orientation. /p
