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Archiviertes Projekt - Development Engineer- medical devices

Firmenname für PREMIUM-Mitglieder sichtbar

November 2020

Dezember 2021

CH-Switzerland

auf Anfrage

02.11.2020

CR/104209_1604076213

Projektbeschreibung

We have an exciting project for an engineer to support the design, development and documentation of existing electromechanical medical devices.

Your responsibilities:

Support activities related to Design Engineering, Quality, Regulatory, Design Changes
Update technical documentation (e.g. Product Risk Management, Design Requirements, Design Outputs) according to MDR regulations and internal processes
Perform the required activities (e.g. create rationales, decision finding protocols) and generates the appropriate PD documents to ensure compliance with national and international regulations related to medical devices (MDR, US FDA, Japanese PAL, ISO 13485)
Designs, develops, and improves electromechanical medical devices according to product development specification
Investigation of issues of products on market (NC, SCAR, CAPA, Complaint)
Works with manufacturing during the design stages to incorporate manufacturability into the product designs and during the implementation phase
Develops test set-ups (including derivation of benchmarks) and coordinates the activities required to fabricate test parts and - complete testing (according to PD process)
Provide knowledge and compliance with laws and policies that apply to the job and ensure a high level of professionalism, ethics and compliance at all time

Profile:
Master/ bachelor's degree in mechanical or mechatronics engineering
At least 3 years of experience in the design and development of medical devices
Business fluent in German and English
MS Office (Work, Excel) knowledge is required
Creative/problem-solving skills
Good documentation practice (GDP) knowledge
CAD knowledge preferably PTC Creo
Analytical skills

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