Job Overview
Our client is a leading medical device company that develops innovative heart support devices. Their goal is to provide interventional cardiologists with effective and less invasive solutions.
The company's diverse team consists of professionals from various backgrounds and expertise, located in the Netherlands and Galway, Ireland.
Job Description:
Support the development and implementation of manufacturing processes for the company's pVAD catheter. Provide feedback & input on design aspects and collaborate with suppliers of catheter components.
Work closely with device development and characterization teams, other development functions, and Quality Assurance departments.
Key Responsibilities:
- Develop and optimize manufacturing processes, materials, and methods as part of the product development team.
- Design, specify, procure, and qualify process fixtures and equipment.
- Create and maintain Work Instructions and supporting documentation for manufacturing processes.
- Execute process characterisation and validation activities.
- Serve as a technical expert in assembly and manufacture, providing guidance to colleagues.
- Embed quality into all aspects of work by ensuring compliance to quality requirements.
- Collaborate with internal cross-functional teams and external partners.
Required Skills and Qualifications:
- Minimum 3 years of experience in medical device development with a relevant engineering degree.
- Experience in fabrication and manufacture of catheter-based medical devices.
- Strong skills in product and process development, including fixture and equipment design, validation of processes, and Work Instructions development.