Head of Product Development - System Architect A Product Developer / System Architect is sought to join anestablished start-up atthe forefront of innovation in the international MedTech Sector. Working on one of the hottest and most relevant topicsof today – Women's Health and premature birth the Head of Product Development will lead thedevelopment and execution of a Class III/PMA (FDA Regulation) & Class IIb(MDR) Clinical Diagnostic Platform strategy for innovative healthcaretechnology. Your responsibilitieswill include defining product requirements and scope, as well as driving theproduct development process from concept to launch. With a background in activemedical devices (medical devices with electrical components), you will bewell-equipped to contribute to the success of the company. The role can be based in either Barcelona or Bilbao. Key responsibilities Develop systemarchitectures, and describe functions, interfaces, requirements, and risksduring product development projects to establish files for hardware andsoftware Partner with projectmanagement as technical lead Actively design and maintainan efficient effective requirements and product risk management process Control implementation ofsystem architecture requirements during product development, and product lifetime Train and moderaterequirements, risk management sessions and design reviews Work closely and build effectiverelations with key contacts, communicate effectively with internal and externalparties (users, suppliers) Maintaincompliance with QSR and ISO regulations and procedures Ensure data accuracy andcomplete, consistent documentation Requirements Bachelor's degree or higher in scientific, engineering ormedical technology disciplines E xperiencein system architecture,requirements and risk management for software and hardware products of MedicalDevices E xperience with active medical devices (medical deviceswith electrical components) and of working under-regulated product developmentwith very high safety requirements Experience in the development of class II orIII active medical devices (ideally you will have placed Medical Devices into theUSA/Europe market in a similar role already Knowledge of MDR/FDA regulations and standards (ISO13485,ISO14971) Ademocratic team culture that encourages everybody to contribute ideas andacquire new skills Flexibility– we're hiring your skills and experience, so we ask you to use these in themost effective way Salaryin accordance with your profile and experience. Additional benefits including PhantomShares plan. Byjoining this international business, you will have the chance to make a differencebecoming part of a project that will impact the lives and health of millions ofpregnant women and newborns around the globe. #J-18808-Ljbffr
