Certification Engineer - Medical devices

City:Warsaw, Poland

Type:Full-time

About us

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.

Key Responsibilities

  • 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).

Requirements

  • 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

Great office

  • Superb location, walking distance from Metro Racławicka

  • Parking spots without parkometers

  • Excellent coffee (!)

  • Balcony for summer chilling

Salary

  • From 6K PLN net