Job title: Principal Engineer – R&D
Location: ATU iHub, Dublin Road, Galway
Role:
As a Principal R&D Engineer, you 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 integrate effectively with delivery systems.
Company:
Based in GMIT, they are developing solutions for problems in embolization. Embolization is a minimally invasive procedure used to treat, for example, internal bleeding or benign and malignant tumors.
Responsibilities:
1. Lead technical and project activities throughout the product lifecycle, from design to regulatory approval.
2. Translate user needs into design specifications, ensuring compliance with industry standards and user requirements.
3. Perform FEA analysis and lead structural reliability programs for nitinol-based implants.
4. Design and guide the development of prototypes, test methods, and evaluation processes.
5. Select materials, define assembly methods, and oversee sourcing, testing, and approval of components.
6. Manage risk throughout the product lifecycle, ensuring product quality, durability, and manufacturability.
7. Develop and execute technical documentation, including product design history and device master records.
8. Lead the technical team to meet project goals on time and within budget.
9. Collaborate with physicians to validate product solutions and user needs.
10. 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.
- 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.
Does this sound like your next career move? For more info, forward your application or contact me at 087 0612325 or via email at thomas.gallagher@lifescience.ie
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