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Medical Device Innovation Specialist
2 weeks ago
R&D Design Engineer
About the Role:We are seeking a creative and hands-on engineer to drive the design and development of new medical devices, with a strong focus on catheter technology.
This is a key role in the entire product lifecycle, from initial concept and prototyping to regulatory submission and manufacturing transfer.
The successful candidate will be a problem-solver who thrives in a fast-paced R&D environment.
Key Responsibilities:- Design & Development: Lead the design of innovative catheters and other 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.
- 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.
This role offers opportunities for professional growth and development in a dynamic and innovative company.