Senior Process Development Engineer
This is an exciting opportunity to advance your career in the heart of Ireland's MedTech hub.
Role Overview
The Senior Process Development Engineer will play a pivotal role in the New Product Development (NPD) team, contributing to the creation and optimisation of minimally invasive catheter shaft solutions.
Key Responsibilities
* Lead the development of catheter shafts, managing projects from feasibility to validation and production transfer.
* Identify and implement improvements to enhance efficiency, quality, and cost-effectiveness while maintaining compliance with regulatory standards.
* Partner with PMO, Operations, Quality, and other teams to ensure smooth process integration and development.
* Builid strong relationships with customers, providing technical leadership during calls and site visits.
* Address design and process challenges during feasibility, development, validation, and manufacturing.
* Prepare comprehensive documentation aligned with regulatory requirements and industry standards.
* Champion continuous improvement initiatives, contributing to new methodologies, technologies, and solutions.
* Provide guidance to junior engineers, fostering a culture of learning, collaboration, and innovation.
Qualifications and Experience
* Educational Background: Level 8 degree in Engineering, Science, or a related field.
* Industry Experience: At least 5 years of experience in a Medical Device New Product Development (NPD) environment.
* Core Expertise: Proven proficiency in catheter shaft manufacturing techniques, including braiding, coiling, thermal reflow, and bonding.
* Methodologies: Experience with Lean Six Sigma, Design of Experiments (DOE), and process optimisation tools such as Minitab.
* Material Knowledge: Understanding of biocompatible metals and polymers.
* Leadership: Demonstrated ability to lead teams through FMEA, DOE, engineering studies, and validation processes.
* Communication Skills: Strong interpersonal and presentation skills, capable of engaging with technical and non-technical stakeholders.
Why Join This Team?
* Be part of a globally recognised MedTech leader in Galway, the heart of Ireland's medical device industry.
* Work on innovative projects that make a tangible difference in healthcare.
* Enjoy professional development in a supportive and collaborative work environment.
* Live and work in County Galway, renowned for its natural beauty, rich culture, and vibrant community.