PERFORMANCE EVALUATION ENGINEER (IVDR)  (M/F/D)
FULL TIME

Platomics is dedicated to bringing the power of personalized medicine into everyday healthcare by making genetic testing easy and affordable. For this purpose, our team applies the most advanced computing technologies to enable big data processing and analysis in healthcare. We are a vibrant team, with backgrounds in bioinformatics, genetics and software development.
 

As a Performance Evaluation Engineer you have the following responsibilities:

• Define and implement the performance evaluation of our IVD software products according to European Regulations (IVDR)

• Create and maintain Performance Evaluation Plans and Reports, including Analytical and Clinical Performance Evaluation

• Define relevant evaluation measures and design study protocols

• Design performance evaluation studies and protocols

• Prepare and submit ethics applications; communication to authorities, e.g. ethics committee, competent authorities

• Management of clinical performance evaluation; coordinate study partners (e.g. in multi-centric trials)

• Collaborate with external stakeholders involved in the performance evaluation, e.g. geneticists or physicians

• Work with cross-functional teams, especially Regulatory Affairs and Quality Management, Engineering
   

Required Qualifications:​

• Experience with Performance Evaluation under IVDD/IVDR, including defining and authoring Analytical and Clinical Performance Evaluation plan and report

• Degree qualification in medicine or related science subject, laboratory and/or medical and/or clinical background

• Industry experience and mindset

• IVDR Regulatory knowledge preferred; MDR optional

• Strong organizational skills

• Excellent communication skills

• Very good English skills, especially writing in English
   

Preferred Qualifications:​

• Knowledge of genetic testing

• Experience in clinical trials (setup and management), ethics applications

• Translation of a device into clinical practice

• Regulatory Experience with reagents, wet-lab, lab chemicals

• Experience with software as medical device (SaMD), software as an IVD

• Experience with medical literature and publication databases

• Knowledge of International Regulations, e.g. FDA

• German language skills
   

We offer:

• Interesting topics in a rapidly growing market

• Challenging and varied tasks

• Flexible work schedule

• Referral program 
   

You’ll earn an appropriate salary starting at EUR 48,370 gross per year (IT-KV). Willingness for over-payment is given for candidates with proper experience and/or qualifications.

The Platomics office is very conveniently located close to Praterstern, easily reachable via U1, U2, S-Bahn and ÖBB. 

​

Apply via: careers@platomics.com or call +43 660 710 93 70