Process Development Engineer / R&D Tech Transfer (Medical Devices)

Prunus Italy, Italian subsidiary of Prunus Medical, is a young, innovative, and fast-growing medical device company dedicated to bringing new ideas to life and improving patient outcomes. Joining our team means becoming part of a dynamic and collaborative environment where your ideas matter, your work has real impact, and every day brings new opportunities to learn and grow.As we build our processes, facilities, and technologies from the ground up, you’ll have the chance to shape the future of our operations, gain hands-on experience across multiple disciplines, and grow alongside a passionate team that values creativity, initiative, and continuous improvement.If you’re driven by curiosity, eager to learn, and excited to contribute to something new and meaningful — we’d love to have you on our journey. Company OverviewPrunus Medical develops and markets a comprehensive portfolio of high-quality disposables and capital equipment for Critical Care and Anesthesia. The product range includes central venous catheters, blood pressure monitoring systems, thermodilution and embolectomy catheters, bipolar pacing catheters, as well as advanced ventilators and anesthesia machines developed in partnership with leading European institutions.Prunus products are sold in over 70 countries, including highly regulated markets such as Germany, Sweden, Switzerland, the UK, Japan, the USA, and Singapore. To further strengthen its presence in Europe and support the development of innovative devices for the European market, the group has established new subsidiaries in Switzerland and Italy.The growing Italian team is committed to improving patient outcomes through the development and manufacturing of high-quality, safe, and effective medical devices, within a collaborative and innovation-driven environment.Position SummaryThe Process Development Engineer / R&D Tech Transfer Engineer will play a critical role in developing and scaling up manufacturing processes for a new medical device under development. This position will lead process design, equipment selection, cleanroom setup, and technology transfer activities to ensure robust, compliant, and scalable manufacturing operations. The engineer will collaborate closely with R&D, Facility, QA and RA teams to bring the new device from concept to production readiness in alignment with MDR and FDA requirements.Key ResponsibilitiesClosely collaborate with R&D to develop, document, and optimize manufacturing processes for the new medical device from prototype through production scale.Conduct process feasibility studies, trials ensuring scale-up and process validation (IQ/OQ/PQ) in collaboration with R&D and Quality team, including protocol and reporting.Prepare detailed process flow diagrams (PFDs), PFMEAs, and control plans to ensure product quality and reproducibility.Generate and review technical documentation, work instructions, standard operating procedures (SOPs) and train production personnel on new processes and equipment.Support in specify and procure manufacturing equipment and tooling.Ensure alignment with regulatory and quality standards for cleanroom operation and environmental control.Support internal and external audits as a subject matter expert for process development and transfer.Provide technical support for troubleshooting and continuous process improvement.QualificationsEducation:Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field.Experience:5–8 years of experience in medical device product or process development, manufacturing engineering, or technology transfer roles.Hands-on experience with manufacturing environment, equipment setup and qualification, process validation, and documentation under ISO 13485/FDA.Proven track record in scaling processes from prototype to production.Familiarity with risk management (ISO 14971), design control and validation principles (IQ/OQ/PQ).Skills:Strong problem-solving and analytical skills with attention to detail.Proficiency with CAD tools, statistical software (e.g., Minitab), and Microsoft Office.Excellent communication and technical writing skills in Italian and English.Ability to work effectively in a cross-functional, fast-paced environment.