Highly motivated and results-driven Mechanical Engineer with 25+ years of experience leading and delivering complex projects in regulated, high-volume manufacturing environments. Proven ability to translate concepts into robust, reliable, and user-friendly products, with a strong focus on medical diagnostics and point-of-care solutions.Adept at building and inspiring high-performing engineering teams, fostering a culture of collaboration, innovation, and excellence. Expertise in the full product development lifecycle, from concept to commercialisation, ensuring adherence to quality standards and regulatory requirements.Key Skills:• Medical Device Development: Point-of-care diagnostics, system architecture, design for manufacture, regulatory compliance (ISO 13485 & 14971).• Product Development: Concept generation, prototyping, testing, verification, validation, design transfer, manufacturing scale-up.• Engineering Management: Team leadership, mentoring, resource allocation, budgeting, project planning, risk management.• Technical Expertise: Mechanical engineering, systems engineering, mechatronics, design analysis, problem-solving.Passionate about leveraging engineering expertise to drive innovation and improve healthcare outcomes. Eager to connect and explore new opportunities where I can contribute to the development of impactful medical technologies.Contact: edward.hele@gmail.com
Listed skills include Engineering, Mechanical Engineering, Product Design, Project Management, and 28 others.