Job title: Operations Engineer
Location:Galway West Business Park
Benefits:Competitive salary, Share options, excellent opportunity to develop your experience and career in an exciting start up helping develop a product from its very early stages.


Company:
My client an early-stage medical device start-up company focused on the design and development of novel devices for the treatment of Intracranial Atherosclerotic Disease. This is a new and evolving treatment area likely to be the next frontier in Neuro-intervention.



Overview:
You will play a key role in overseeing and optimizing our manufacturing processes for neuro medical devices. This individual will collaborate closely with cross-functional team members to ensure the efficient production of high-quality products that meet regulatory standards and exceed customer expectations.





Responsibilities:

• Lead the design, implementation, and continuous improvement of manufacturing processes for the company’s flagship device, encompassing product assembly, testing, and packaging.
• Provide hands-on technical support to the manufacturing line, ensuring smooth day-to-day operations and swift resolution of issues.
• Proactively monitor line performance, efficiency, and output, using data-driven insights to drive improvements.
• Ensure all manufacturing activities are conducted in compliance with the company’s Quality Management System (QMS) and applicable policies, including accurate documentation and comprehensive reporting.
• Identify and implement efficiency enhancements to streamline manufacturing workflows and reduce waste.
• Support the introduction of new product lines by establishing robust manufacturing processes, tooling, and fixtures.
• Plan, execute, and document process validation activities in alignment with regulatory and quality system requirements.
• Participate in process risk assessments and contribute to mitigation strategies to ensure robust manufacturing operations.
• Lead and support continuous improvement initiatives focused on optimizing product yield, reducing cycle time, and maximizing resource utilization.
• Collaborate cross-functionally with R&D, Quality Assurance, and Regulatory Affairs to ensure compliance with industry regulations and internal standards.
• Develop, review, and maintain detailed process documentation including work instructions, inspection procedures, and batch records to ensure clarity, traceability, and compliance.
• Maintain full traceability of finished goods in accordance with regulatory and internal requirements.
• Manage equipment lifecycle activities, including specification, procurement, installation calibration, and preventive maintenance.
• Represent the company during external engagements such as physician line tours, showcasing manufacturing capabilities and quality practices.
• Coordinate with suppliers regarding delivery schedules, quality concerns, and continuous improvement opportunities.