Overview
Location: Sligo
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
The Role
We are seeking a creative and hands-on R&D Project Engineer to drive the design and development of new medical devices, with a strong focus on catheter technology. You will be a key player in the entire product lifecycle, from initial concept and prototyping to regulatory submission and manufacturing transfer. This role is perfect for a problem-solver who thrives in a fast-paced R&D environment.
Key Responsibilities
* Design & Development: Lead the design of innovative catheters and other Class I/II/III medical devices using SolidWorks.
* Prototyping: Rapidly build and test new concepts using hands-on skills, including 3D printing and various lab processes.
* Regulatory Compliance: Ensure all design work and documentation adhere to the quality management system (ISO 13485) and meet design controls for FDA & CE submissions.
* Collaboration: Work closely with cross-functional teams, including Quality, Regulatory, and Manufacturing, to ensure project success.
Skills & Qualifications
* Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
* Proven experience in medical device design, with a strong preference for catheter design.
* Expert proficiency in SolidWorks.
* In-depth understanding of the design process and controls within an ISO 13485 environment.
* Excellent hands-on skills in prototyping and lab testing.
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