Job Title: Process Engineer - Medical Device Development
About the Role:
We are seeking a highly skilled Process Engineer to join our team in developing innovative medical devices. The successful candidate will be responsible for designing and implementing manufacturing processes, materials, and methods associated with our product development team.
Responsibilities:
* Develops manufacturing processes, materials, and methods as part of the product development team
* Designs, specifies, procures and qualifies process fixtures and equipment
* Develops Work Instructions and other supporting documentation for manufacturing processes
* Executes process characterisation and validation activities
* Becomes a technical expert in the assembly and manufacture of our products, and provides technical guidance to other team members
* Supports cleanroom setup, fit-out & validation
* Evaluates relevant process & manufacturing technologies and strategically identifies opportunities to implement them
* Executes project plans, tasks and deliverables. Manages time to meet project deadlines
* Uses structured problem-solving techniques and statistical methods for data driven analysis and decisions
Required Skills and Qualifications:
* Minimum of three years of medical device development experience
* Primary or Master's Degree in a relevant engineering discipline such as polymer, mechanical, manufacturing or biomedical engineering
* Experience in fabrication and manufacture of catheter based medical devices; experience in large calibre delivery systems is an advantage
* Product and process development, and new product introduction skills in medical devices are a must
About Us:
We are a leading innovator in the field of medical devices. Our team consists of enthusiastic individuals with diverse backgrounds and expertise located in Ireland and Netherlands. We strive to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device.