Chief Technical Officer for Medical Innovation

1 week ago

Galway, Galway, Ireland beBeeEngineering Full time €60,000 - €80,000
Job Title

Technical Lead for Medical Device Development

About the Opportunity

Lead a team of engineers in the design, development and testing of medical devices.

Responsibilities
  • Manage 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.
  • Oversee product/Process optimization projects – in liaison with Supply Chain and Quality.
  • Acquire an 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.
  • Direct 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.
  • Investigate product complaints and analyze returned devices.
  • Support CAPA and Non-Conformance process.
  • Evaluate and scope process changes, material changes, vendor changes.
  • Support labeling changes and implementation.
Qualifications
  • 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 design and technical ability based on a broad and deep knowledge of fundamental engineering principles.

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