Process Development Specialist

5 days ago

Galway, Galway, Ireland beBeeDevelopment Full time €80,000 - €110,000

Our team is seeking an innovative Process Development Engineer to join our product development team. This role offers a unique opportunity to contribute to the development of a new and innovative medical device that supports heart health.

The ideal candidate will have hands-on knowledge and experience in both cardiovascular device development and manufacturing processes, with a strong focus on quality and regulatory compliance. They will work closely with cross-functional teams to develop and implement manufacturing and assembly processes, design feedback & input, as well as working with suppliers of catheter components.

Required Skills and Qualifications:
  • Minimum of three years of medical device development experience, and a degree in a relevant engineering discipline such as polymer, mechanical, manufacturing or biomedical engineering.
  • Experience in fabrication and manufacture of catheter-based medical devices, particularly large calibre delivery systems.
  • Product and process development, and new product introduction skills in medical devices.
Job Description:

This role involves developing manufacturing processes, materials, and methods as part of the product development team, using in-house and external development paths. You will also be responsible for designing, specifying, procuring, and qualifying process fixtures and equipment, as well as executing process characterization and validation activities.

As a technical expert in assembly and manufacture, you will provide guidance to other team members and ensure that all aspects of work maintain compliance to quality requirements. Additionally, you will work with internal cross-functional teams and contract manufacturers or design firms to ensure system design, architecture, and verification/validation meets design input.

Responsibilities:

  1. Develops manufacturing processes, materials, and methods
  2. Designs, specifies, procures, and qualifies process fixtures and equipment
  3. Executes process characterization and validation activities
  4. Becomes a technical expert in assembly and manufacture

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