StellenbeschreibungABOUT FORTIL Fortil 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. JOB DESCRIPTION As part of the expansion of our activities in French-speaking Switzerland , we are looking for an R&D Technical Leader – Disposable Kits (M/F). Reporting to an Engineering Manager, you will support the development and lifecycle management of innovative disposable products used within the Medical Device and Biopharmaceutical industries. Working 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. Your main responsibilities will include: Lead sustaining engineering activities for existing products throughout their lifecycle. Drive engineering change implementation related to products, materials, suppliers and manufacturing processes. Assess technical impacts and risks associated with product modifications. Coordinate verification activities required to support engineering changes. Collaborate closely with Quality, Regulatory Affairs, Manufacturing, Supply Chain and external suppliers. Support root cause investigations and continuous improvement initiatives. Ensure product quality, compliance and continuity of supply. Maintain technical documentation according to quality management requirements. Contribute to technical decision-making while ensuring project execution, planning and stakeholder alignment. YOUR PROFILE You 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. Required experience 5 to 10 years of experience in Product Development, Sustaining Engineering or Product Lifecycle Management. Experience managing Engineering Change processes. Experience working in regulated environments (Medical Device or Biopharma). Experience collaborating with manufacturing sites and external suppliers. Previous involvement in multidisciplinary technical projects. Experience supporting product lifecycle activities from development to industrialization. Technical skills Product Lifecycle Management (PLM) Engineering Change Management Risk Assessment Design Control principles Verification & Validation Root Cause Analysis Continuous Improvement Technical Documentation Additional assets Experience with disposable or single-use products. Knowledge of plastics, tubing, injection moulding or medical assemblies. Familiarity with ISO 13485 requirements. Supplier Quality experience. Languages Professional English is mandatory. French is considered a strong asset. WHY JOIN FORTIL? At Fortil, we provide a stimulating environment where talented engineers can continuously develop their expertise. We offer: Continuous learning and career development. Opportunities to work on cutting-edge international projects. An entrepreneurial environment encouraging initiative and innovation. The possibility to become a shareholder within the Group. Participation in meaningful CSR initiatives. A people-first culture supporting work-life balance and professional growth. Fortil is committed to equal opportunities. All applications are considered regardless of gender, age, disability, ethnic origin, religion or sexual orientation.
