PRR Project

Summary

This position is intended for the exercise of scientific research activities in the scientific area of Mechanical Engineering in the R&D unit 2AI. The prospective employee will be involved in the development of 2AI’s strategic program, specifically in the design and development of innovative medical devices, while also contributing with devices for industrial applications. Additionally, the scientific profile aims to enhance 2Ai´s excellence by developing advanced and realistic phantom, anatomical models, or mock models to fulfill 2AI’s goals of providing specialized services for medical training and technology validation. Overall, the candidate will focus on the development of physical interfaces, physical models, and mechanical components, using state-of-the-art additive manufacturing technologies. Emphasis will be given to usability and interaction design, ensuring that medical devices meet the needs of both healthcare providers and patients. Moreover, since 2AI aims to meet the necessary criteria for medical certification, focus will be given on maintaining a quality management system to manage risk, ensure regulatory compliance, organize documentation, and track product lifecycle of the medical devices developed. Thus, the selected candidate will be responsible for the main tasks: 1. Design and development of devices:  ???????Development of medical and industrial devices from the conceptualization to the implementation stages.Developing physical interfaces for surgical navigation systems.Guiding the integration process of hardware and software in physical products, such as sensors, actuators, and digital interfaces.Utilizing additive manufacturing techniques to fabricate the developed medical devices and medical phantoms, aiding in the simulation, and testing of medical procedures.Applying principles of usability design to enhance user interaction with medical devices, ensuring ease of use and improving patient outcomes.Collaborating with interdisciplinary teams, including clinicians and other engineers, to integrate clinical needs with engineering solutions. 2. Quality management:In the development of medical devices, the candidate will ensure compliance with regulatory requirements, such as IEC 62366-1. This is essential for facilitating certification processes, aligning with 2AI´s ambition for ISO 13485, and also ISO 14971, certification.Maintaining a quality management system, according to the requirements of the abovementioned ISO 14971 and ISO 13485.Maintaining documentation throughout the development process in compliance with medical device regulations (e.g., MDR, FDA, CE marking).Conducting testing and validation of the devices including preclinical and clinical evaluations. 3. Scientific production, project management, and supervision:???????Publish research papers, organize or participate in conferences, and give lectures in medical device design and development.Assisting with undergraduate courses, mentoring junior students, or guiding new lab members.Collaborate with the Valorization Innovation Center (VIC) in the process of protection of the generated intellectual property, and further dissemination or commercialization.To fulfill these tasks, a defined scientific profile will be searched:PhD in Mechanical Engineering, with experience in usability and product design for industrial and medical devices, or a closely related field.Knowledge of additive manufacturing processes and materials suitable for medical use.Experience in usability and interaction design, with a portfolio demonstrating past projects in medical device development.Analytical skills and the ability to apply engineering principles to solve design problems.Communication skills for effective teamwork and presentation of findings to stakeholders.The need for this scientific profile is driven by the increasing demand for innovative solutions in healthcare and industry. In fact, the technological advancements and the growing need for personalized and precise medicine offer unique opportunities for innovation in the development of medical devices. The integration of additive manufacturing into the development of medical devices allows for efficient customization, while also allowing the creation of accurate anatomical models for medical training. Furthermore, the emphasis on usability is crucial for ensuring that medical devices meet the required needs, ultimately improving patient care and safety. Hiring an individual with mechanical engineering expertise and design proficiency can give a significant push to innovate in medical device development. Keeping compliance with regulatory requirements is essential for medical device development, as it may facilitate regulatory approval in various markets. It helps build confidence among customers and stakeholders by demonstrating a commitment to quality and safety in the development of medical devices.    ????