Senior Technical Innovator

2 weeks ago

Galway, Galway, Ireland beBeeEngineering Full time €90,000 - €120,000

Job Title: Technical Innovation Specialist

We are seeking an experienced Technical Innovation Specialist to support managing and delivering technical activities associated with the lifecycle management of our portfolio of products for treatment of acute ischemic stroke. The role involves overall responsibility for various aspects of the product's lifecycle, including material changes, process improvement, regulatory submissions, shelf-life studies, responding to sales & marketing requests, and returned product investigations.

Key Responsibilities:

  • Technical project optimization projects – in liaison with Supply Chain and Quality.
  • Acquire a comprehensive knowledge of current products from a technical point of view: design, materials, performances, manufacturing process. Support second supplier and/or technical transfer projects.
  • Manage project sub-parts, as part of a larger project team.
  • Provide direction to other team members, including mentoring and oversight of less experienced engineers or technicians.
  • Support regulatory submissions and lead additional Design Verification/Validation studies as required by regional authorities.
  • Lead product Shelf-Life studies through Design Verification testing.
  • Investigations on product complaints and analysis of returned devices
  • Support to Corrective Action and Preventative Action processes.
  • Evaluation and scoping of process changes, material changes, vendor changes.
  • Support to Labeling changes and implementation.

Requirements:

  • A minimum of 5 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing) is required.
  • Mechanical or biomedical engineering degree or equivalent.
  • Specific experience on Medical Devices, cardiovascular or neurovascular implants or instruments including catheters, stents, delivery systems.
  • Strong technical ability based on a broad and deep knowledge of fundamental engineering principles.

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