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 *****) 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 ***** environment.
Excellent hands-on skills in prototyping and lab testing.
#Gertek To start the process click the Continue to Application or Login/Register to apply button below.