Product Development Engineer

2 weeks ago

Galway City, Ireland Life Science Recruitment Full time

About Us:

Our client is a medical device start-up that is pioneering a revolutionary approach to treating acute decompensated heart failure by leveraging the vital role of the lymphatic system in restoring fluid balance.

What We Offer:

We are committed to fostering a culture of innovation and collaboration, where our team members can thrive and grow professionally. Our company is a dynamic, rapidly growing organization seeking to make a meaningful impact in the medical device industry.

The Role:

  • Work as part of our Technical Operations team on new product development projects, supporting process development and optimization, scale-up and technology transfer.
  • Research and deliver complex processes and technologies to accelerate time-to-market for the next generation of devices.
  • Develop manufacturing processes while adhering to Design for Manufacture (DFM) and Design for Assembly (DFA) principles.
  • Support production builds & yield improvement activities, including problem solving, root cause analysis & solution development.
  • Develop fixtures & equipment through all phases of design, documentation, implementation, spares & maintenance.
  • Evaluate, with the team, the process, design, and supply chain risks and develop strategies to highlight, monitor, manage and mitigate these risks.
  • Support design transfer to manufacturing activities.
  • Deliver high quality products.

Requirements:

  • Bachelor's degree in Biomedical, Mechanical, Polymer, Manufacturing, Materials, or Industrial Engineering.
  • A Masters or PhD in a related field is advantageous.
  • 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.
  • Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles and medical device processing technologies.
  • Experience in the development and production of medical devices that require complex processes.
  • Excellent oral and written English language and communication skills.
  • Working visa for Ireland.

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