Senior NPI Process Development Engineer

Job Summary: In this role, the candidate will be a core member of a cross functional teams responsible for developing and delivering complex acute ischemic stroke projects with significant technical challenges from initial concept through to commercialisation. The candidates primary responsibility will be to work with the product development team, the suppliers of raw materials, and suppliers of manufactured assemblies, from individual components to final packaged, sterilised devices. The role will be involved throughout the entire product and process development cycle from initial prototyping through to process validation and commercialisation. The key goals will be to ensure that optimal materials, suppliers, and manufacturing processes are selected and developed to deliver a high quality, capable, right- first-time product output at maximum yields and efficiencies to achieve/exceed manufacturing quality and cost targets. Duties and Responsibilities Work collaboratively on cross-functional project teams to develop robust product design to ensure capable manufacturing processes (Design for Manufacture). Evaluate critical to quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications that ensure components are manufacturable and performance is maintained consistently. Assess new and existing raw materials, component, and assembly suppliers for technical and manufacturing capabilities. Drive process/product improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design. Manage prototype builds to support characterization and develop assessment strategies. Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing line and pilot lines. Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place for components and finished devices. Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met. Monitor supplier performance and provide technical support to resolve issues. Implement changes under the change management system. Other duties as assigned or required. Required Experience & Education Degree in Mechanical or Biomedical Engineering or equivalent. At least 5-7 years of medical device medical process/device design and development experience in a regulated environment. Desirable Experience Prior experience in medical device catheter process design and or manufacturing is highly desirable. Understanding of product lifecycle and validation requirements for new product introduction. Experienced in developing validation strategies for equipment or processes, including preparation of FMEAs protocols and reports. Proficiency in structured problem-solving approaches (e.g. Six Sigma, DMAIC) Project Management experience, developing project schedules and managing resources and execution. Experience in managing technical relationships with external suppliers and OEM is preferred. Design tools and practices expertise including Design for Manufacture, Lean assembly, SolidWorks, Prototyping and Test method development. Strong understanding and proven experience using appropriate statistical tools throughout each project lifecycle stage. Excellent communication / interpersonal skills required. Ability to multi-task, working on multiple projects simultaneously. High level of technical writing and reporting skills. Strong work ethic, creative problem solving, capable of working on own initiative. Skills: Product Development product lifecycle DMAIC Project Management