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Nextkidney SA (www.nextkidney.com) is a Swiss international 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 operate in Europe, Asia, and the US. You will collaborate with investment funds (VCs), foundations, and companies worldwide and be part of an open, modern working atmosphere where business and human values meet.
Our company mission: create a better life for dialysis patients worldwide!
Design Quality Engineer (100%)
We are looking for a passionate candidate to actively participate in design and development (D&D) phases, including documentation, in compliance with applicable standards.
Key responsibilities and accountabilities:
1. 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, achieving quality and regulatory requirements.
2. Act as an interface between products and processes.
3. Support D&D traceability activities through development stages, ensuring verification and validation processes are carried out and documented.
4. Support D&D in solving process and product-related problems by developing and implementing solutions, facilitating design change control, and ensuring standards compliance.
5. Support risk management activities (e.g., RMF, RMA, D-/P-FMEA, RMP, RMR) and ensure risk control measures are implemented in design and production.
6. Identify and initiate process improvements both locally and company-wide, including with external 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 in moderating discussions and presenting ideas.
* Fluent in English; French is a plus.
Education and experience:
* Bachelor’s or master’s degree in engineering or related technical field.
* Experience with international standards and regulatory regulations for medical devices, especially hardware, software, and consumables.
* Experience in design quality, quality management, and assurance in regulated industries (ISO 13485, IEC 60601, IEC 62304).
* Experience in risk management within medical technology is advantageous.
Start of the mission:
As soon as possible.
Activity rate:
100%.
We offer:
* Participation in innovative projects with a team of experts.
* Access to the latest technologies.
* A dynamic working environment emphasizing collaboration.
To apply:
Send your cover letter and resume to hr@nextkidney.com. Note: Only candidates with a Swiss passport or from UE-27/AELE will be considered.
Seniority level:
* Entry level
Employment type:
* Full-time
Job function:
* Quality Assurance
Industries:
* Medical Equipment Manufacturing
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