Job Description
A Senior NPI Process Development Engineer is required to work with a Galway based medical device manufacturing client on a contracting basis…. initial 12-month contract.
Role of this position
1. Assess new and existing raw materials, component, and assembly suppliers for technical and manufacturing capabilities.
2. Drive process/product improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design.
3. Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing line and pilot lines.
4. 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.
5. Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met.
6. Monitor supplier performance and provide technical support to resolve issues.
JOB REQUIREMENTS
7. Degree in Mechanical or Biomedical Engineering or equivalent.
8. At least 5-7 years of medical device medical process/device design and development experience in a regulated environment.
9. Experience in managing technical relationships with external suppliers and OEM is preferred.