Job Title
We are seeking a skilled Medical Device Design Engineer to join our award-winning organization based in Galway.
Duties and Responsibilities
* Collaborate with cross-functional project teams to develop robust product design ensuring capable manufacturing processes.
* Benchmark and assess 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, validate and ensure inspection methods and controls are in place for components and finished devices with suppliers and incoming inspection laboratories.
* 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.
* Evaluate critical to quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications ensuring components are manufacturable and performance is maintained consistently.
Requirements
* Mechanical or Biomedical Engineering degree 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 in executing validation of equipment or processes, including preparation of protocols and reports (OQ/PQ).
* Understanding of product lifecycle and validation requirements for a new product introduction.
* Experience in using a structured problem solving approach is highly desirable (e.g green belt, DEMAIC).