We are currently recruiting for an exciting opportunity with a leading multinational medical device organization based in Galway.
Duties
* Collaborate with cross-functional project teams to develop robust product design, ensuring capable manufacturing processes.
* Build and assess device prototypes to support characterization.
* Work on manufacturing 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.
* Assess new and existing suppliers for technical and manufacturing capabilities.
* Identify process improvements related to sub-assembly or component usage or design.
* Translate critical to quality requirements into component specifications for complex acute ischemic stroke devices.
Education & Experience
* Bachelor's degree in Mechanical or Biomedical Engineering or equivalent.
* At least 4 years' experience in medical device design and development.
* Prior experience in medical device catheter process design and manufacturing is highly desirable.
* Experience in executing validation of equipment or processes, including preparation of protocols and reports.
* Understanding of product lifecycle and validation requirements for a new product introduction.
* Structured problem-solving approach is highly desirable.