Kerja Sepenuh Masa Product Development Engineer, Gaji tinggi SGD 3,000 di NEXTKIDNEY SG PTE. LTD. West Region (Singapore) - Maukerja

About Us

Nextkidney SG is a subsidiary of Nextkidney, a Dutch medical technology company based in Singapore. We are focused on the development of sorbent-based dialysate regenerative device for use in a portable hemodialysis device. Our vision is to be the global leader in making portable dialysis affordable and accessible to all.

Learn more about us at *************

Job description

Nextkidney SG is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. A Product Development Engineer contributes to activities across the product lifecycles. This role blends technical engineering with product realization in a regulated med-tech environment.

Responsibilities

• Participate in all product development lifecycles, from concept stage through design, prototyping, component procurement, assembly, test, verification, and validation, and to manufacturing, product launch and post-launch support.

• Support, coordinate, and execute in continuous improvements projects, cost-down projects, and sustaining activities to meet the clinical and business needs.

• Implement product and process improvement through design and process modification in response to end user-derived inputs or clinical feedback, including prototyping.

• Conduct root cause analysis and post-incident reviews for product and process improvement.

• Design of experiments and engineering testing for proof of concept.

• Ensure compliance of work to QMS and ISO13485 standards.

• Conduct proof of concept study

• Conduct design verification and validation testing.

• Development and writing of technical documentation to ensure equipment or process meet specifications and regulatory requirements.

• Execute engineering change control and document change control activities; participate in change control reviews.

• Support the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.

• Support the fabrication, assembly, and validation of device/ prototypes to ensure compliance to specifications.

• Support manufacturing and production process improvement

• Actively work with the team and part suppliers throughout the product cycle

Requirements

• Bachelor's Degree of Science in the field of Mechanical Enginering or related discipline.
• A minimum of 1 year experience, preferably in biotech or medical device industries
• Possess good knowledge of ISO09001, ISO13495 QMS, preferably with auditing experience, will be an advantage
• Experience in statistical analysis and quality tools is a plus.
• Experience in packaging design is an added advantage.
• Understanding of dialysis-specific product lifecycle and technologies is a plus.
• Highly motivated individuals with the ability to work under minimal supervision.

Come join our team!