Product Development Engineer

NEXTKIDNEY SG PTE. LTD.; Santo Niño 1st; Sur place; PHP 300 000 - 600 000; Plein temps

Résumé du poste

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 span from concept through design, prototyping, verification, validation and manufacturing, with emphasis on QMS/ISO13485 compliance and collaboration with suppliers to

Qualifications

• Bachelor's Degree in Science in Mechanical Engineering or related discipline.
• Experience in biotech or medical device industries is preferred (1 year).
• Familiarity with quality tools and statistics is a plus.

Responsabilités

• Participate in all product development lifecycles from concept through manufacturing and post-launch support.
• Support continuous improvement, cost-down projects and sustaining activities.
• Conduct design verification and validation testing and documentation to meet regulatory requirements.

Connaissances

Statistical analysis

Quality tools

Formation

Bachelor's degree in Mechanical Engineering or related field

Outils

ISO9001

ISO13485

Description du poste

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 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. 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!