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Innitius is seeking a highly skilled and strategic Head of Product Development (System Architect) to join our Product Development team. In this role, you will have the opportunity to lead the development and execution of our Class III/PMA (FDA Regulation) & Class IIb (MDR) Clinical Diagnostic Platform strategy for our innovative healthcare technology. Your responsibilities will include defining product requirements and scope, as well as driving the product development process from concept to launch. With a focus or background in healthcare, you will be well-equipped to bring a valuable perspective to this role and contribute to the success of our company. If you have a passion for driving product innovation in the MedTech industry, we encourage you to apply for this exciting opportunity. About INNITIUS: We are at the forefront of innovation in the international MedTech Sector, working on one of the hottest and most relevant topics of today – Women's Health and premature birth. By joining our team, in whatever role, you will get to make a true impact on the lives of others. Recently funded by the EIC Accelerator and leading Healthtech Investors as Clave Capital and Nara Health Capital, you will be part of a project that will impact the lives and health of millions of Pregnant women and newborns around the globe! Tasks The position’s role is: to own the product technology landscape, to develop system/ software architectures and requirements for products, and to manage their risk files accordingly over the whole product life cycle. You will further develop and maintain our requirements and risk management process in order to achieve conformity with applicable quality standards. Strong leadership skills are necessary to drive architectural and risk management tasks and to coordinate the applicable stakeholders ( eg management and SMEs, internal and external, different company functions) High engineering acumen, and deep analytical and structural thinking are required to develop the system architecture along industry standards. Requirements Develop system architectures, and describe functions, interfaces, requirements, and risks during product development projects to establish files for hardware and software Partner with project management as technical lead Actively design and maintain an efficient and effective requirements and product risk management process Control implementation of system architecture, requirements during product development, and product lifetime Train and moderate requirements, risk management sessions and design reviews Work closely and build effective relations with key contacts, communicate effectively with internal and external parties (users, suppliers) Maintain compliance with QSR and ISO regulations and procedures at all times. Coordinate with internal/ external parties and stakeholder in a cross-functional team. Ensure data accuracy and complete, consistent documentation at all times. Cover all needed activities via an adequate project management planning and reporting. Leadership Profile: Due to the nature of the targeted process area, you must have a relentless positive approach and 'can do' attitude. Excellent communicator Approachable Patient Enthusiastic and able to motivate staff. Able to influence and persuade. Highly organized, methodical with strong people skills, able to adapt to the audience. Education and Knowledge profile: Bachelor’s and master’s degree in medical technology, engineering, sciences or similar experience in system architecture, requirements, and risk management for software and hardware products of Medical Devices experience with active medical devices (medical devices with electrical components) and worked under-regulated product development with very high safety requirements experience in using requirements tools experience in the development of class II or III active medical devices (E2E -ideally you have placed 2 to 5 Medical Devices into the USA/Europe market in a similar role already knowledge of FDA/ MDR regulations and standards (e.g. ISO13485, QSR, ISO14971) fluent English Benefits Aside from this, we provide all the necessary support and perks to make your life at work and outside of work fun and comfortable all year round, such as: Flexibility – we’re hiring your skills and experience, so we ask you to use these in the most effective way. At the moment we are working from the offices (Bilbao and Barcelona), however, we are comfortable offering remote work as well. A democratic team culture that encourages everybody to contribute ideas and acquire new skills, we have regular catchups as a global team and have the opportunity to work cross-functionally as needed. The person who joins the company will be able to develop his or her professional career within a rapidly expanding Startup. Salary in accordance with your profile and experience. Additional benefits (Stock options / Phantom Shares plan) can be evaluated.