We develop, manufacture and market innovative, high-quality medical devices in the field of in vitro diagnostics. Our systems are tailored to professional applications in hospitals, out-patient clinics and medical laboratories.
Our interdisciplinary teams are highly motivated and built on a broad range of technical expertise. We have a strong technical foundation in mechatronics, mechanical and electrical engineering, as well as in various scientific fields such as chemistry, physics, mathematics, life sciences and biomedical analytics. Additionally, our team excels in software and firmware development.
We are always looking for committed and innovative people who want to grow with us.

PRODUCT MANAGER / CLINICAL VALIDATION ENGINEER [MMS] (F/M/D)

To support our team and product portfolio, we are currently looking for a product manager/clinical validation engineer based in Graz

YOUR EDUCATION

• University degree (technical university / university of applied science ) in biomedical engineering/science or similar field

• Establish procedures for performance evaluation & design validation studies according to relevant regulations (e.g. IVDR), standards (e.g. ISO 13485) and guidelines (e.g. CLSI)
• Coordinate with external partners to ensure compliance of clinical evaluations with certification/registration requirements (e.g. notified body)
• Plan (time, content, resources) and perform activities associated with in-house design validation and clinical performance studies
• Manage documentation (e.g. templates, documentation framework) and prepare submission performance study data
• Review literature for inclusion in validation and post-market surveillance procedures
• Validate tools used in design validation & performance evaluation activities
• Coordinate multi-site evaluation of IVD product & first customer evaluations in Europe
• Create customer information, training material and package inserts for IVD products