Principal Engineer R&D
Based at the ATU iHub in Galway, we are seeking a highly skilled Principal R&D Engineer to lead product development for an implantable device.
Key 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 teams to meet project goals on time.
* Collaborate with physicians to validate product solutions and user needs.
Requirements
* Permanent implant design experience in peripheral vasculature/cardiology or structural heart, including specification generation and test method development.
* Expertise in nitinol-based implants and structural reliability programs.
* Experience with FEA and SolidWorks for design and analysis.
* Minimum 7 years of experience in mechanical design and product development within medical devices.
* Strong knowledge of FDA, GMP, QSR, ISO 13485 standards, and design life cycles.
* Proven project management skills (schedule development, budgeting, resource planning).
* Experience with in vitro and in vivo assessments and implant/tissue interface challenges.
* Experience with Class II or III medical devices and clinical trials.