Senior Process Development Engineer
In the heart of Ireland's MedTech hub, we are seeking a Senior Process Development Engineer to play a pivotal role in our New Product Development (NPD) team.
This key position will focus on creating and optimising minimally invasive catheter shaft solutions, working closely with cross-functional teams and customers to drive innovation and ensure seamless project execution from initial concept through to commercial release.
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.
* Build 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:
* Educated to Level 8 degree in Engineering, Science, or a related field.
* At least 5 years of experience in a Medical Device New Product Development (NPD) environment.
* Proven proficiency in catheter shaft manufacturing techniques, including braiding, coiling, thermal reflow, and bonding.
* Experience with Lean Six Sigma, Design of Experiments (DOE), and process optimisation tools such as Minitab.
* Understanding of biocompatible metals and polymers.
* Demonstrated ability to lead teams through FMEA, DOE, engineering studies, and validation processes.
* Strong interpersonal and presentation skills, capable of engaging with technical and non-technical stakeholders.
About This Role:
* 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.
This role offers the perfect balance of professional challenge and an outstanding quality of life in beautiful Galway.
The estimated salary for this role is €90,000 - €120,000 per annum, depending on experience.