We are seeking a highly skilled and innovative R&D Design Engineer to drive the design and development of new medical devices, with a strong focus on catheter technology. This is a unique opportunity to 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 and has expertise in designing and developing medical devices using SolidWorks.
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.
Requirements
* 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.