Title: Operations Manager
Location: Galway Business Park, Galway
Benefit: Competitive salary, Bonus of 10% and share options


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



Role:
As an highly experienced Operations Manager to join their dynamic team. The successful candidate 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. practices.


Requirements:
- Bachelor's degree in engineering or a related technical field.
- Minimum of 3 years of experience in Operations engineering within the medical device industry, preferably with neuro interventional devices.
- Strong understanding of basic engineering principles.
- Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485
- Experience with risk management methodologies, such as ISO 14971, and application to medical device development.
- Proficiency in process validation techniques, including protocol development, execution, and documentation.



Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]