Junior RD Engineer

AVVie is an exciting early stage medical device company with an innovative minimally invasive technology for the treatment of mitral valve disease.

This is a key role in the design and development of a structural heart device bringing it through all phases of the development cycle into clinical studies. This position offers tremendous growth opportunity as the company is still in the formative stage.

Tasks

Primary responsibility is to design and develop novel transcatheter mitral valve devices in our prototyping

lab in Vienna.

Contribute to product development and validation projects.

Improve products in collaboration with other teams.

Define and design the manufacturing processes and protocols of the products.

Design prototype and assembly of soft components for in house testing.

Participate in technical assessment qualification and selection of external partners/vendors.

Working and documenting compliant with MDR ISO 13485:2016/A11:2021 FDA 21 CFR Part 820

and AVVies IMS processes

Collaborate with the other teams (especially QM Regulatory and Medical) to ensure that the

products are designed in a technically valid and clinically relevant manner.

Stay up to date on the latest research and trends in the field.

Writes related periodic status reports of related projects.

Other duties assigned by direct supervisor.

Requirements

Work experience and education in Biomedical Engineering (Master level) or similar.

Experience in polymer science and metal processing

12 years of experience in product development (design test and release).

Previous experience with surgical fabrics and biomaterials (plus)

Wellorganized with a high level of attention to detail and accuracy.

Comfortable working both independently and on a team within a fastpaced and flexible startup

environment

Great communication skills internally and externally

Fluent in English at a professional level

Comfortable building your own structures and aligning them with company goals

Great analytical skills as well as ability to crossrelate information from different topics and areas

(RA biotech medical product development)

Ability to adapt as well as to work under pressure and tight deadlines

Benefits

Minimum salary of 2.36918 gross per month (fulltime) depending on experiences.