We are seeking an experienced Medical Device Design Engineer to join our award-winning organization in Galway.
This is an excellent opportunity for individuals who want to work with a leading multinational company that excels in its field.
Duties and Responsibilities:
* Collaborate with cross-functional project teams to develop robust product designs ensuring capable manufacturing processes.
* Buildevaluate device prototypes to support characterization.
* Work on manufacturing lines/pilot lines with external suppliers to characterize and validate new and improved manufacturing processes and components.
* Develop and validate inspection methods and controls with suppliers and incoming inspection laboratories 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.
* Evaluate new and existing suppliers for technical and manufacturing capabilities.
* Identify process improvements related to sub-assembly or component usage or design.
* Assess critical to quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications.
Education and Experience:
* Bachelor's degree in Mechanical or Biomedical Engineering or equivalent.
* A minimum of 4 years' experience in medical device design and development (including design).
* Prior experience in medical device catheter process design and/or manufacturing is highly desirable.
* Experience executing validation of equipment or processes, including preparation of protocols and reports.
* Understanding of product lifecycle and validation requirements for a new product introduction.
* Experience using a structured problem-solving approach (e.g., green belt, DEMAIC) is highly desirable.