AVVie is an exciting early stage medical device company with an innovativeminimally invasive technology for the treatment of mitral valve disease.
If you are interested in joining a young and international startup active in medical technology in Vienna.
Tasks
Primary responsibility is to design and develop novel transcatheter mitral valve devices in our prototyping lab in Vienna working collaboratively with a multidisciplinary R&D team.
- Collaborate with the R&D team to design and develop a novel transcatheter mitral valve repair device aligned with user needs.
- Generate creative solutions to challenges and contribute to innovation by supporting patent filings.
- Oversee the daily operations of the inhouse prototyping lab including lab management.
- Identify design and implement new testing procedures tailored to the features of the products with a focus on quality and regulatory compliance.
- Develop detailed component and finished device assembly drawings/specifications in line with user needs and design inputs.
- Identify and manage key risks throughout the product lifecycle.
- Write and review test protocols reports technical summaries and other essential deliverables.
Requirements
- Degree in Mechanical Engineering Biomedical Engineering or related fields.
- 12 years of experience in the medical device industry preferably in structural heart disease or nitinolbased products.
- Experience with transcatheter medical device testing product development or steerable delivery systems is highly preferred.
- Proficiency in 3D CAD software (preferably SolidWorks).
- Working knowledge of FDA GMP QSR and ISO 13485 requirements.
- Strong problemsolving skills and a handson approach to development and testing.
- Startup mentality with the ability to adapt to a fastpaced dynamic work environment.
- Strong team player who can effectively manage time and work independently.
- Fluency in English is mandatory; German is a plus.
- Startup mentality