Principal Engineer - R&D

Job title : Principal Engineer R&D Location : ATU iHub, Dublin Road, Galway Role : As a Principal R&D Engineer will lead product development for an implantable device through design, verification, clinical trials, validation, and regulatory approval.

This individual will work closely with the R&D team to ensure the implant designs meet user needs and integrates effectively with delivery systems.

Company : BasedinGMITtheyaredevelopingsolutionsforproblemsinembolization.Embolizationisaminimallyinvasiveprocedurethatcanbeusedtotreat,forexample,internal bleedingorbenignandmalignanttumors Responsibilities : - Lead technical and project activities throughout the product lifecycle, from design to regulatory approval.

• Translate user needs into design specifications, ensuring compliance with industry standards and user requirements.
• Perform FEA analysis and lead structural reliability programs for nitinol-based implants.
• Design and guide the development of prototypes, test methods, and evaluation processes.
• Select materials, define assembly methods, and oversee sourcing, testing, and approval of components.
• Manage risk throughout the product lifecycle, ensuring product quality, durability, and manufacturability.
• Develop and execute technical documentation, including product design history and device master records.
• Lead technical team to meet project goals on time and within budget.
• Collaborate with physicians to validate product solutions and user needs.
• Support design integration into manufacturing, ensuring robust processes and quality control.

Requirements : - Permanent implant design experience in peripheral vasculature / cardiology or structural heart, including specification generation and test method development.

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