Technology Lead

Email Trilingual Executive Assistant at The Blue BoxWe are looking for a Tech Lead to join our dynamic team and spearhead the technical aspects of our breast cancer diagnostic device development. The ideal candidate will possess a strong technical background, exceptional leadership skills, and a passion for driving innovation in healthcare. Main responsibilities:Lead the final steps of the design and development process of a medical device for breast cancer detection. Observe the device being used in a real setting (clinical trials and post-market), and come up with future implementations to mitigate risks and improve experience. Lead, together with the company’s management team (CEO, COO, CSO), the technical strategy and roadmap for product development, ensuring alignment with company goals and objectives. Lead improvements in AI algorithms based on processing and data analysis of clinical examinations gathered with the device. Lead troubleshooting efforts and provide technical expertise to resolve complex issues encountered during development. Drive innovation and optimization of the diagnostics device technology, leveraging the latest advancements in engineering, biology, and materials science, as well as clinical data for the improvement of AI software diagnostic tools. Collaborate with subcontractors and manufacturing partners to set up production lines for the manufacturing of the diagnostic device, ensuring adequate knowledge transfer from the design and development process. Define production procedures, protocols, and standards to ensure consistent and efficient manufacturing processes. Define required in-process and end-process controls that will be required to ensure product quality. Work closely with the Sales department to manage production rounds, ensure stock availability, and manage production resources to meet client yearly supply requirements. Work closely with regulatory affairs to prepare and submit documentation for regulatory approvals and compliance. Ensure that all technical aspects of the diagnostic device development adhere to quality standards, regulatory requirements, and industry best practices. Address customer complaints and feedback regarding product performance, functionality, or usability, and work collaboratively with cross-functional teams to implement corrective actions and improvements. Lead the technical support to customers, clinicians, and end-users, assisting with troubleshooting, installation, training, and maintenance of the diagnostic device. Qualifications:Advanced Degree in Industrial Engineering, Biomedical Engineering, Computer Science, or related field. Project Management Experience: Experience collaborating with subcontractors and manufacturing partners to set up production lines, ensuring knowledge transfer from design and development processes, and defining production procedures, protocols, and standards. Proven track record of technical leadership and hands-on experience in the development and production of medical devices or diagnostic technologies, preferably in a related field such as oncology or female health. Expertise in product development methodologies, production setup, manufacturing processes, and quality assurance. Experience in developing and improving AI algorithms, particularly in the context of processing and analyzing clinical examination data gathered from medical devices is a plus. Strong knowledge of regulatory requirements for medical devices (e. g. , CE marking, ISO 13485) and experience navigating the regulatory pathway for product approvals will be positively evaluated. Passion for making a positive impact in healthcare and improving patient outcomes through innovative technology solutions. Strong leadership skills to lead the technical strategy and roadmap for product development, ensuring alignment with company goals and objectives. Excellent communication, interpersonal, and leadership skills, with the ability to effectively collaborate with internal and external stakeholders. Fluency in English. Knowledge of additional European languages is a plus. If your application can not go through LinkedIn, please send it to . aiAbout the teamThis is an in-person job with one optional work-from-home day per week. Our office space is at StartUB! coworking lab in Barcelona and we’ll be occasionally conducting lab work in Poblenou. The current team is integrated by 8 people: CEO, CTO, COO, Clinical lead, QA/RA Manager, Project Manager, Lab Technician, and R+D Engineer. Know more about us at thebluebox. ai. About the companyWomen lack reliable breast cancer (BC) screening methods, as 50% of BCs are detected in a late stage. At The Blue Box, we've developed a radiation-free, pain-free, low-cost device detecting breast cancer from volatile organic biomarkers in urine with a sensitivity of 88%. This outperforms mammography by 15% across all age groups and by 30% for women under 50. By 2025, we aim to introduce this solution in gynecology clinics through a software-driven business model. 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