Certification Engineer - Medical devices
Mudita, a consumer electronics company supported by the founder of CD Projekt – Michał Kiciński.operating Mudita together with BIRN medical foundation created a medical ventilator which is currently being registered for pandemic use in FDA. Currently willing to further develop the product is looking for a skilled Medical Certification Engineer for our team in Warsaw.
Complete leading of certification process. Direct contact with certification bodies;
Analysis of technical and formal requirements for designed products;
Cooperation with Electronics and Mechanical department in order to verify if designed product meets specific requirements;
Tracking of regulatory requirements in EU and global market. Taking care of implementation modifications in design and documentation to meet possible changes.
Preparation of required product specification and internal documentation in order to present appropriate design to certification body;
Active participation in the development of the device (from design phase to serial production).
Higher technical education – electronics or related;
2 years of work experience on similar position;
Knowledge of IEC60601-1 and ISO 14971;
Knowledge of certification processes related with consumer electronics will be an advantage;
Knowledge of EU directives, standardized and legal requirements used for conformity assessment;
Experience in preparing technical documentation, certification process and product registration according to legal requirements;
The ability to present the results of analyzes and document the progress in project;
Experience in carrying out or planning product tests in external laboratories and the ability to formulate assumptions from completed test plan;
Using Polish and English on level that allows free communication;
Ability to work independent and accuracy.
Cool working environment
Freedom and transparency
Flexible working hours
Multisport Benefit Card
Medicover Health Care
Vooom Mobility Benefit Package
Superb location, walking distance from Metro Racławicka
Parking spots without parkometers
Excellent coffee (!)
Balcony for summer chilling
From 6K PLN net
Please send your CV or LinkedIn profile to:
(Please include the position name in the e-mail title)
Please include the following clause in your CV:
“I agree to the processing of my personal data contained in the application documents provided by me in order to carry out the recruitment process by Mudita sp. z o.o. in Warsaw, Jana Czeczota Street No 9. I give my data voluntarily, I know the right to access and correct them, and that consent may be revoked at any time.”