Job Title: Product Development Engineer
Location: Galway, Ireland
This is an hourly contract role supporting the Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector. The successful candidate will be responsible for developing and delivering complex acute ischemic stroke projects with significant technical challenges.
Key Responsibilities:
* 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/pilot lines with external suppliers to characterize and validate new and improved manufacturing processes and components.
* Develop and implement inspection methods and controls 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.
Requirements:
* Mechanical or Biomedical Engineering degree or equivalent.
* A minimum of 4 years' experience in medical device design and development, including design with SolidWorks, prototyping, testing.
Desirable Experience:
* Prior experience in medical device catheter process design and manufacturing.
* Experience 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.