Job Description:
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1. Role:
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This is an exciting opportunity for someone passionate about developing their career in the Medical Device industry.
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2. Responsibilities:
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3. Work as part of the Technical Operations team on new product development projects, supporting process development and optimization, scale-up and technology transfer.
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4. Research and deliver complex processes and technologies to accelerate time-to-market for the next generation of devices.
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5. Develop manufacturing processes while adhering to Design for Manufacture (DFM) and Design for Assembly (DFA) principles.
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6. Support production builds & yield improvement activities, including problem solving, root cause analysis & solution development.
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7. Develop fixtures & equipment through all phases of design, documentation, implementation, spares & maintenance.
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8. Evaluate, with the team, the process, design, and supply chain risks and develop strategies to highlight, monitor, manage and mitigate these risks.
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9. Support design transfer to manufacturing activities.
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10. Deliver high quality products.
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11. Requirements:
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12. Bachelor's degree in Biomedical, Mechanical, Polymer, Manufacturing, Materials, or Industrial Engineering. A Masters or PhD in a related field is advantageous.
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13. 1+ years of engineering experience working for a MedTech company whose products and processes are FDA regulated. Experience of good manufacturing practice (GMP) in a cleanroom is advantageous.
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14. Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles and medical device processing technologies.
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15. Experience in the development and production of medical devices that require complex processes.
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16. Excellent oral and written English language and communication skills. Can express themselves spontaneously, fluently, and precisely, differentiating finer shades of meaning even in complex situations.
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17. Working visa for Ireland.
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Company:
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My client is a medical device start-up who is a dynamic, rapidly growing organization, seeking to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.
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Key Skills:
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Manufacturing Engineer, Biomedical Engineering, Medical Device Industry, Process Development, Technology Transfer, Design for Manufacture, Design for Assembly, Root Cause Analysis, Quality Control, Supply Chain Management.
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What We Offer:
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A competitive salary, bonus, and share options, along with the opportunity to work with new technologies and contribute to the development of innovative medical devices.