Nextkidney SA (www.nextkidney.com) is a Swiss international operating company developing Medical Devices located in Lausanne, with its head office in The Netherlands.
Nextkidney SA, is a fast-growing innovative company developing and commercializing the world’s first portable hemodialysis device. We do business in Europe, Asia and US. You will collaborate with Investment funds (VC’s), foundations and companies all over the world and be part of an open modern working atmosphere where business and professional human values meet.
Our company mission: create a better life for Dialysis patients all over the world!
Design Quality Engineer (100%) - ( Permanent contract + Maternity Leave Cover)
For our Quality department, we are looking for a passionate candidate to actively participate in design and development (D&D) phases and their documentation, in compliance with the applicable standards.
Key responsibilities and accountabilities :
* Ensure compliance with requirements according to 21CFR Part 820, Directive 93/42/EEC, Regulation (EU) 2017/745, ISO 13485, ISO 14971, IEC 60601, IEC 62304, ISO 62366, ISO 80601-2 and the company's quality manual and achieve quality and regulatory requirements.
* Act as an interface between products and processes.
* Support design and development documentation (e.g., DHF).
* Support D&D traceability activities through the successive development stages and monitor that the necessary verification and validation processes are carried out and documented.
* Support D&D in solving process and product-related problems, by developing and implementing solutions for elimination and prevention, and by facilitating the design change control process, while ensuring the compliance with applicable standards.
* Support risk management activities (e.g. RMF, RMA, D-/P-FMEA, RMP, RMR[JR1] ) and ensure that the risk control measures are implemented in the design and production processes.
* Identify and initiate process improvements and to this end take responsibilities both locally and company-wide, as well as with external development partners and suppliers.
Knowledge, skills, and abilities :
* Broad understanding of engineering disciplines involved in medical devices (mechanics, electronics, software, chemistry).
* Strong organizational skills and attention to detail.
* Good written and oral communication skills.
* Confident appearance and enjoyment in moderating discussions.
* Fluent in English, and preferably in French.
Education and experience :
* Bachelor’s or master’s degree in engineering or experience in a related technical field with a comparable educational background.
* Experience with international standards and regulatory regulations for medical devices, preferably in the field of hardware, software integrated, and stand-alone, consumables are an advantage.
* Experience in the field of design quality, quality management, and quality assurance in medical or another regulated industry in compliance with regulations (u.a. ISO 13485, IEC 60601, IEC 62304).
* Experience in the field of risk management, ideally in medical technology, is an advantage.
Start of the mission
As soon as possible.
Activity rate
100%.
We offer
* Participation in innovative projects being part of a team of experts.
* Access to the latest technologies.
* A dynamic working environment where collaboration is one of the key elements.
To apply
Please send your cover letter to hr@nextkidney.com along with your resumé.
Important remarks
For this particular position, please note that only candidates possessing a Swiss passport or those from UE-27/AELE.
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