Biomedical Engineer

vor 16 Stunden

Vienna, Österreich AVVie GmbH Vollzeit

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

Primary responsibility is to lead the design, prototyping, and validation of venous catheter systems, ensuring their compliance with technical, clinical, and regulatory standards throughout the product lifecycle.

  • 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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