Opportunity for a highly motivated and detail-oriented R&D Engineer to join a high profile Galway based Start-up team. This Start-up company is well structured and supported, this role offers an Engineer who is early in their career a chance to join a small Start-up who are embarking on a major growth trajectory for 2025.
In this role, as R&D Engineer you will be instrumental in the design, prototyping, and development of novel medical devices. The ideal candidate will have a strong foundation in mechanical engineering, proficiency with SolidWorks, and hands-on experience with 3D printing technologies. This is a unique opportunity to work at the forefront of medical technology, collaborating closely with cross-functional teams to bring new products from concept to reality.
Key Responsibilities
* Design and Development: Create 3D models, assemblies, and detailed technical drawings of medical devices and components using SolidWorks.
* Prototyping: Utilise 3D printing technology to rapidly prototype and iterate on device designs.
* Engineering Analysis: Conduct finite element analysis (FEA), tolerance analysis, and performance testing to ensure product safety, functionality, and compliance with regulatory standards.
* Product Development Lifecycle: Participate in all stages of product development, from concept generation to design for manufacturing (DFM) and design for assembly (DFA).
* Testing and Validation: Develop and execute test plans to validate the mechanical performance and reliability of devices, ensuring compliance with medical device industry standards (ISO 13485, FDA, etc.).
* Documentation: Produce technical documentation, including design history files (DHF), engineering change orders (ECOs), risk assessments, and design reviews.
* Cross-functional Collaboration: Collaborate with quality, regulatory, and clinical teams to ensure device design aligns with user needs and regulatory requirements.
* Problem Solving: Apply critical thinking and root cause analysis to solve complex technical challenges.
Required Skills & Qualifications
* Education: Bachelor’s degree (or higher) in Mechanical Engineering or a related field.
* Experience: 3+ years of experience in R&D or mechanical engineering, preferably within the medical device, healthcare, or similar regulated industry.
* CAD Expertise: Advanced proficiency in SolidWorks for 3D modeling, assemblies, and technical drawings.
* Prototyping Skills: Hands-on experience with 3D printing technologies for rapid prototyping.
* Technical Analysis: Experience with FEA (Finite Element Analysis), DFM/DFA principles, and engineering problem-solving.
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