We are seeking for a highly skilled and experienced Mechanical Engineering R&D professional to lead the dynamic product development team of a fast-growing company with offices in US, UK, and Spain. The company specializes in cutting-edge high-precision medical devices, aiming to revolutionize its area of specialization. Its close-knit team cultivates an environment of creativity, innovation, rapid iteration, and collaboration with scientific, engineering, and operations teams. The environment is dynamic, fast-paced, and requires a self-starter attitude. The ideal candidate will possess a strong background in mechanical engineering, with extensive experience in designing medical devices under ISO 13485 standards. Additionally, they will demonstrate exceptional leadership and management skills, driving the product design process from conception to production while prioritizing user experience and innovation. A strong candidate will have experience bringing physical products to market in highly regulated areas, ideally medical devices, but other areas such as aerospace and energy could also be relevant.Responsibilities:Lead and mentor a team of product designers and engineers, fostering a culture of creativity, collaboration, and excellence.Oversee the design and development of mechanical components and assemblies for medical devices, ensuring compliance with ISO 13485 standards.Drive feasibility studies, research and development, and testing of new and existing designs, utilizing a user-centered approach.Collaborate closely with cross-functional teams including R&D, manufacturing, quality, and regulatory affairs to deliver successful projects on time and within budget.Facilitate design transfer to manufacturing and provide technical guidance and support during production.Develop and maintain comprehensive product design documentation, including design history files, risk management files, and technical specifications.Lead design reviews, verification and validation testing, and root cause analysis of design-related issues, ensuring continuous improvement.Drive innovation by exploring new technologies and methodologies to enhance product design and performance.User experience and product design-oriented emphasizing aesthetics, ergonomics, and usability.Requirements:Bachelor's degree in Mechanical Engineering or related field; Master's degree preferred.10+ years of experience in mechanical engineering, ideally with a focus on medical device design under ISO 13485 standards.Proven leadership experience, with a track record of successfully managing and motivating cross-functional teams.Expertise in CAD software such as SolidWorks, Pro/Engineer, OnShape, or similar, with a strong emphasis on design for manufacturability.
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