Role: Staff Manufacturing Project Engineer Location: Ballybrit, Galway Reports to: Manufacturing Manager At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Job Summary: The Staff Manufacturing Project Engineer works as part of a multi-functional team in the development and production of medical devices used for the treatment of stroke. They provide production, process and risk management expertise to ensure that our medical devices are appropriately designed and manufactured to successfully treat ischemic stroke. This includes providing technical expertise within the manufacturing engineering team tasked with the production of acute ischemic stroke devices, particularly in the areas of polymer/metal forming and micro assembly processes. Production support activities such as process validation, risk assessments and vendor management are core to the role. As this position will be responsible for working on a portfolio of projects, strong project management skills and experience of working in a matrix organization are highly desired. The role and Responsibilities + Technical SME for Supply chain interaction with outside suppliers, vendors, and/or consultants as required, inclusive of supplier visits and identification / implementation of process improvements. + Manage the implementation and validation of new/updated components to support the assembly of our neurovascular products. + Identify and implement opportunities for improved efficiency. Proactive monitoring of line efficiency, performance and output using Lean / Six Sigma methodologies. + Leads proposals and cost estimates of project/process related costs or cost improvements. Liaises with appropriate functions and external suppliers to provide financial cost evaluations for projects. + Generates capital equipment appropriations required for new process implementation and controls expenditures to ensure compliance with timing and budget requirements. + Maintains product design and process knowledge for assigned products. + Applies broad scientific and engineering knowledge to the required design changes of medical device products, including associated validations. + Establish relationship with external manufacturer ensuring production targets are achieved. + Completion and review of process risk analysis and ongoing dedication to risk reduction. + Provide design for manufacture feedback/support to R&D team during new product development phase. + Applies advanced statistical methods and performs mathematical calculations to resolve manufacturing processes, staff requirements, and production standards. + Performs analytical problem solving and utilises structured decision-making skills. + Generates written protocols and reports to support assigned projects. + Applies verbal and written communications skills in periodic and special reports and presentations both internally and with customers. + Gives technical mentorship to junior engineers/technicians. **Qualifications** Education and Experience: + Mechanical or biomedical engineering degree or equivalent. + Minimum of 7 years’ experience within a GMP regulated Operations Department environment. + Experience in managing complex cross functional projects. + Knowledge of financial accounting and analysis methods to assess product standard costs, project values, and capital requirements. + A strategic team-player, with deep-rooted initiative and accountability. + Inherent critical thinking and problem-solving skills. + Experience in special processes, for example, catheter assembly, polymer processing (compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing), welding, equipment & tool design. + Working knowledge of six sigma and/or lean engineering principles with a proven track record in use and delivery of results! Desirable + Production / line support experience within a medical device environment. + Experience of technology transfer and process optimisation. + People management experience. What is it like to work at J&J MedTech Neurovascular Galway? + Culturally, we are putting the needs of Our Credo stakeholders first through pursuing the highest standards of quality, compliance, and ethics, ensuring everyday actions contribute to Our Purpose. + We are continuing to better our understanding of clot science, through our Neuro Thromboembolic Initiative (NTI). This is a commitment to advance the treatment of stroke through interdisciplinary collaboration and investment in clot and stroke research. How we understand clots and their behaviour enhances our opportunity to design devices that improve patient outcomes and, overall, advance the treatment of acute ischemic stroke. \#LI-CH2