Job Title: Process Development Engineer
Location: Galway, Ireland
About Us:
We specialize in developing innovative devices to support the heart. Our goal is to overcome current limitations by providing cardiologists with more effective and less invasive devices.
Description:
You will support the development and implementation of manufacturing processes for our pVAD catheter as a Process Development Engineer. You will work closely with device development and characterization teams, ensuring high-quality products. The ideal candidate has hands-on experience in cardiovascular device development and manufacturing processes.
Responsibilities:
* Develops manufacturing processes, materials, and methods for product development
* Designs and procures process fixtures and equipment
* Creates Work Instructions and documentation for manufacturing processes
* Executes process characterisation and validation activities
* Provides technical guidance to team members on assembly and manufacture of products
* Maintains quality compliance throughout all aspects of work
* Collaborates with internal teams and contract manufacturers to ensure system design meets requirements
* Evaluates process technologies and identifies opportunities for improvement
Requirements:
* Minimum 3 years of medical device development experience with a degree in engineering (polymer, mechanical, manufacturing, or biomedical)
* Experience in fabrication and manufacture of catheter-based medical devices
* Product and process development skills in medical devices, including fixture and equipment design and process validation