Job Title: Senior 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: As a Senior Operations Engineer, you will join our dynamic team and play a key role in overseeing and optimizing our manufacturing processes for neuro medical devices. You will collaborate closely with cross-functional teams to ensure the efficient production of high-quality products that meet regulatory standards and exceed customer expectations.
Responsibilities:
1. Lead the design, implementation, and optimization of manufacturing processes for the pivotal device, including but not limited to product assembly, testing, and packaging.
2. Provide technical support to the manufacturing line.
3. Proactive monitoring of line efficiency, performance, and output.
4. Ensure manufacturing activities are managed in accordance with the company’s quality system and policies, including diligent recording of results and writing reports.
5. Identify and implement opportunities for improved efficiency.
6. Establish new manufacturing processes and fixtures to facilitate the introduction of new product lines.
7. Define and complete process validation activities as required in accordance with the Quality System.
8. Participate in risk assessments and mitigation activities related to manufacturing processes.
9. Drive continuous improvement initiatives to optimize production yield, cycle time, and resource utilization.
10. Collaborate with R&D, Quality Assurance, and Regulatory Affairs teams to ensure compliance with regulatory requirements and industry standards.
Requirements:
1. Bachelor's degree in engineering or a related technical field.
2. Minimum of 5 years of experience in Operations engineering within the medical device industry, preferably with neuro interventional devices.
3. Strong understanding of basic engineering principles.
Does this sound like your next career move? To apply and for more info, forward your application to the link provided or contact me at 087 0612325 or thomas.gallagher@lifescience.ie.
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