**About Your New Employer**
A small medical device company in Galway is undergoing a period of expansion. The company specializes in developing innovative, clinically proven solutions for treating neurovascular diseases.
About Your New Job:
* Lead root cause analysis efforts to implement product fixes, modifications, and design improvements.
* Monitor, troubleshoot, and determine the root cause of product issues escalated to the design team.
* Collaborate with stakeholders (e.g., vendors, customers, production, quality teams) to ensure safe and reliable product performance.
* Work closely with internal cross-functional teams, contract manufacturers, and design firms to align system design, architecture, and validation with design requirements.
* Act as a key liaison between customers and internal teams, ensuring clear and effective communication.
* Serve as the subject matter expert (SME) for assigned product platforms.
* Apply structured problem-solving techniques and statistical analysis to drive data-informed decisions.
* Partner with internal departments (e.g., Manufacturing, Supply Chain, Quality) to optimize processes, materials, and logistics for commercial products.
* Ensure designs align with company objectives for quality, cost, and timelines.
* Manage projects as needed, including planning, execution, and communication of tasks and deliverables to meet deadlines.
* Embed quality into all aspects of work, ensuring compliance with regulatory and company standards.
* Support the transition of new products from engineering to manufacturing.
* Provide technical guidance and mentorship to engineers and technicians.
Requirements:
* A graduate in Mechanical Engineering/Technical field with typically 3-5 years in a medical device environment or equivalent.
* Product and process development skills in medical device manufacturing are a must.
* Strong knowledge of materials and process capabilities for catheter-based medical device implants is an advantage.
* Strong working knowledge and ability to use statistical techniques, Six Sigma and DFSS methodology.
* Proficient in MATLAB is an advantage.
* Fundamental knowledge of Solid Works, ACAD and FE.
* A valid visa and work permit for Ireland are required.