About Us
Nextkidney SG is a subsidiary of Nextkidney, a Dutch medical technology and is company based in Singapore. We are focused on the development of sorbent based dialysate regenerative device for use in a portable hemodialysis device. It allows for low volume of 5L dialysate fluid per treatment instead of 25 to 30L.
Our vision is to be the global leader in making portable dialysis affordable and accessible to all.
Learn more about us at www.nextkidney.com
Job description
Nextkidney SG is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. As part of the R&D team , you will influence the development of a new generation of home hemodialysis device, as it transitions from design to mass production.
Responsibilities
- Perform conceptual and detailed design
- Perform FEA/CFD simulation to validate design margin, tolerance analysis, FMEA and PFMEA, as required
- Optimize design for manufacturing -
- Conduct impact analysis to achieve optimized design solution to meet design specification, project schedule and cost target.
- Design and execute design verification testing.
- Development, writing and release of manufacturing documentation to ensure equipment or process meet specifications and regulatory requirements.
- Lead and assist in engineering change control and document change control activities; participate in change control reviews.
- Lead and support the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.
- Coordinate the fabrication, assembly and validation of device/ prototypes to ensure compliance to specifications
- Work with the Manufacturing team and part suppliers throughout the product cycle in a fast-paced environmen
- Other duties as assigned
Requirements
- Bachelor's Degree of Science in the field of Mechanical Enginering, Biomedical engineering or related discipline.
- A minimum of 1 year experience, preferably in medical device industry.
- Possess good knowledge of ISO09001, ISO13495 QMS
- Strong knowledge and experience in product design and mechanisms, and product industrialization is preferred
- Experience in using Quality tools (eg: 5 core tools for IATF, Cause & Effect Diagram, Histogram, pFMEA, SPC and others).
- Proficient in CAD tools like Solidworks and other simulation tools
- Experienced in performing supplier audits and supporting supplier qualifications. plus issuing and reviewing supplier non-conformances (SCARs).
- Experience in packaging design is an added advantage
- Highly motivated individuals with the ability to work under minimal supervision.
Come join our team!
Please reply with your resume and expected salary
