Senior R&D Engineering Lead

1 week ago

Galway, Galway, Ireland beBeeEngineering Full time €80,000 - €120,000
Job Opportunity

A senior position is available for a Research and Development Engineer to lead various aspects of the product's lifecycle.

About the Role

This is an opportunity to work on challenging projects, including material changes, process improvement, regulatory submissions, and responding to sales & marketing requests.

Key Responsibilities
  1. Overall responsibility for various stages of the product's lifecycle.
  2. Product/Process optimization projects – in liaison with Supply Chain and Quality.
  3. Acquire in-depth knowledge of current products from a technical point of view: design, materials, performances, manufacturing process. Support second supplier and/or technical transfer projects.
  4. Manage project sub-parts, as part of a larger project team.
  5. Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
  6. Support regulatory submissions and lead additional Design Verification/Validation studies as required by regional authorities.
  7. Lead product Shelf-Life studies through Design Verification testing.
  8. Investigate product complaints and analyze returned devices.
  9. Support CAPA and Non-Conformance processes.
  10. Evaluate and scope process changes, material changes, vendor changes.
  11. Support labeling changes and implementation.
Required Skills and Qualifications
  1. A minimum of 5 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing) is required.
  2. Mechanical or biomedical engineering degree or equivalent.
  3. Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments including catheters, stents, delivery systems.
  4. Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles.
Benefits
  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Opportunities to work on challenging projects and assignments.
  • Possibilities for further personal and professional development/education.
  • Excellent benefits.

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