Manufacturing ManagerABOUT THE COMPANYAn innovative medical technology start-up with operations in Ireland is developing next-generation imaging solutions that aim to transform healthcare and address significant global clinical challenges. With a strong focus on engineering excellence, creativity, and collaboration, the company is building advanced hardware, software, and data science technologies that push the boundaries of medical imaging.To support continued growth, the team is seeking an experiencedManufacturing Managerto lead manufacturing activities and oversee partnerships with key manufacturing partners across Ireland and mainland Europe. This position will require regular on-site engagement with these partners.THE ROLEThe Manufacturing Manager will be responsible for developing, implementing, and maintaining best-in-class manufacturing processes in collaboration with internal teams and contract manufacturers. The successful candidate will establish robust process controls, support design transfer, and scale production from prototype to volume manufacturing, ensuring all operations align with business objectives, quality standards, and regulatory requirements.This is a hands-on leadership role in a dynamic start-up environment, offering the opportunity to shape the future of medical imaging technology.KEY RESPONSIBILITIESDevelop and manage efficient manufacturing processes, including materials planning, production scheduling, and product release for use.Partner with R&D on new product development, focusing on Design-for-Manufacturing (DFM) and seamless design transfer to internal or external manufacturing operations.Build and maintain strong relationships with third-party manufacturing partners.Travel regularly to company and partner manufacturing sites across Ireland and Europe.Lead reviews of manufacturing progress, challenges, and production analysis, driving alignment across project and functional teams.Maintain manufacturing documentation, including Device Master Records (DMR) and Device History Records (DHR).Ensure compliance with Quality Policy and applicable quality system requirements.Create and manage the annual manufacturing budget, including cost and capacity modeling.Lead continuous improvement initiatives to enhance efficiency, reduce costs, and scale production.Promote a collaborative, high-performance culture within the manufacturing function.EXPERIENCE & QUALIFICATIONSBachelor's degree in Engineering or related discipline with a minimum of 10 years' experience, including at least 5 years in a leadership role within a regulated industry.Proven experience working under ISO 13485 and/or FDA-regulated quality systems, with a strong understanding of risk management methodologies.Skilled in Design-for-Manufacturing (DFM), Lean manufacturing, and Six Sigma techniques.Experience managing global, cross-functional teams and manufacturing partners.Experience with sterile disposable medical devices (e.g., intravascular catheters) and/or complex hardware systems is advantageous.Demonstrated ability to manage budgets, drive cost improvements, and scale production operations.Excellent communication, organizational, and leadership skills.Previous start-up experience is a plus.Flexible, proactive problem-solver with a collaborative mindset.WHAT'S ON OFFEROpportunity to work on cutting-edge medical imaging technologies that directly improve patient care.A dynamic, international team culture focused on innovation, collaboration, and professional growth.A flexible, learning-driven work environment with opportunities to expand your technical and leadership skills.Offices in Ireland and Germany, with flexible working arrangements and international exposure.