Beschreibung
Device Development Engineer for Medical Devices and IVDs (m/f/d)
Reference: -en
Start: asap
Duration: 3 MM++
Main tasks:
- Development and Change-Management of (sterile, non-sterile) medical devices (class I and IVD Medical Devices)
- Preparation of risk analyses and support for approval documentation in cooperation with quality management and suppliers
- Create and maintain necessary documentation (i.e. technical file, risk assessment, clinical evaluation etc.)
- Cooperate with external partners and suppliers
- Monitor consistency/compliance of production
Main qualifications
- Academic degree in medical engineering, plastics (injection molding) technology or natural science degree (e.g. biology, chemistry, physics, optics, medical technology) or equivalent qualification
- In-depth knowledge of 21 CFR 820 and ISO 13485:2016 “Product Realization” requirements (including Product Risk Management according to ISO 14971, Product Usability according to ISO 62366, Clinical Evaluations according to Meddev 2.7.1 Rev. 4)
- Profound experience in IVD and /or Medical Device Development
- Strong analytical, quantitative and project management skills
- Experience in medical device production with focus on plastic production
- Strong team player who enjoys working and learning in a highly interdisciplinary and dynamic environment
- Excellent German and English skills (oral and written)
Main advantages:
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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