Process Development Engineer

THE ROLE: * 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. * 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.REQUIREMENTS:* 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. * Experience in managing technical relationships with external suppliers and OEM is preferred.