Archiviertes Projekt - Development Engineer for medical devices (m/w/d)

Assignment description:

* Development of medical devices with focus on plastic container systems for irrigation
* Creating and maintaining documentation (verification, qualification and validation) to ensure compliance with 21 CFR 820, ISO-13485 and Medical Device Regulations
* Responsibility of tasks in sub-projects or assignments
* Planning, execution and documentation of Design Verifications for medical devices

Requirement Profile:

* Bachelor degree as mechanical engineer, plastics engineer or comparable education
* 3+ years of job experience with the development of medical devices
* Familiarity (ideally 3+ years of experience) in Product Development Processes (V-Model, Stage-Gate-Model, etc.)

* Knowledge or background in the development for medical devices, including norms and regulations as well as documentation
* Experience in the qualification and verification of medical devices, preferably container systems, is a strong asset

* A structured working methodology and experience in project work is appreciated
* Confident English language skills required (B2 level or better is appreciated)
* High reliability and motivation
* Willingness to travel upon request (not on a regular basis)
* Willingness to be part of an international project team and working target oriented
* High proficiency in MS Office