AVVie is an exciting early stage medical device company with an innovative, minimally invasive technology for the treatment of mitral valve disease.
If you are interested in joining a young and international start-up active in medical technology in Vienna.
Tasks
* Collaborate with the R&D team to design and develop venous catheter systems tailored to clinical and user needs.
* Conduct mechanical and material analyses to evaluate catheter performance, durability, and safety.
* Develop and execute test protocols to validate catheter performance in line with regulatory requirements.
* Utilize CAD software to create detailed catheter designs and technical drawings.
* Perform rapid prototyping and iterative testing to refine designs based on feedback.
* Collaborate with cross-functional teams to ensure compliance with ISO 13485, MDR, and FDA regulations.
* Document technical findings, validation results, and design iterations in technical reports and regulatory submissions.
* Stay updated on advancements in vascular access technologies and integrate new findings into the development process.
Requirements
* Degree in Biomedical Engineering, Mechanical Engineering, or a related field.
* 2+ years of experience in medical device development, preferably with catheter-based or vascular access technologies.
* Proficiency in CAD software (e.g., SolidWorks) and knowledge of material properties relevant to catheter systems.
* Experience with device testing, including mechanical, fluid dynamics, and biocompatibility evaluations.
* Familiarity with relevant standards and regulations, such as ISO 13485, FDA 21 CFR Part 820, and MDR.
* Strong problem-solving skills and a hands-on approach to iterative design and prototyping.
* Ability to work collaboratively in a multidisciplinary team environment.
* Fluent in English; German proficiency is an advantage.
* Start-up mentality.
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