Development Engineer Medical Devices
- Contract
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Development Engineer Medical Devices
Senior Development Engineer – Sustaining Engineering (MDR)
Overall responsibilities
Is responsible for the design and development role for the independently update of the technical documentation of existing electromechanical medical devices according to MDR
Responsibilities
- Update of technical documentation (e.g. Product Risk Management, Design Requirements, Design Outputs) according to MDR regulations and internal processes
- Performs 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)
- Works together with regulatory, quality, technical engineering, external suppliers and manufacturing to release the documents
- 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/ mechatronics/ electrical or design quality 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
- Analytical skills
- Willingness to accept responsibility
- Team player
Non Technical Skills and Additional Details
Non-Technical profile requirements: - Some flexibility in working hours is required - Must be able to work on multiple simultaneous tasks with limited supervision; - Quick learner, motivated self-starter; - Excellent customer service, interpersonal, communication and team collaboration skills; - Able to follow change management for internal guidelines. Language proficiencies: -English and German spoken and written
If you are interested please apply to raffael.jaegle@harveynash.com