Product Development Engineer

NEXTKIDNEY SG PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Nextkidney SG is seeking a Product Development Engineer to contribute across the product lifecycle in a regulated med‑tech environment in Singapore. You will blend technical engineering with product realization to support design, testing, verification and manufacturing initiatives.

The role requires a Bachelor’s degree in Mechanical Engineering and about 1 year of biotech or medical device experience, with familiarity in ISO13485 and QMS.

Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline.
• At least 1 year experience, preferably in biotech or medical device industries.
• Knowledge of ISO 9001/ISO13485 QMS, auditing is a plus.
• Experience with statistical analysis and quality tools is beneficial.
• Knowledge of packaging design is an added advantage.
• Understanding of dialysis-specific product lifecycle and technologies is a plus.

Responsibilities

• Participate in all product development lifecycles from concept through manufacturing, launches and post-launch support.
• Support continuous improvement, cost-down, and sustaining activities to meet clinical and business needs.
• Implement product/process improvements based on end-user inputs and clinical feedback.
• Conduct root cause analysis and post-incident reviews for improvements.
• Design experiments and perform engineering testing for proofs of concept.
• Ensure compliance with QMS and ISO13485 standards.
• Develop and write technical documentation to meet specifications and regulatory requirements.
• Assist in change control and investigations arising from audits or non-conformances.
• Support fabrication, assembly and validation of devices and prototypes.
• Collaborate with team and suppliers throughout the product cycle.

Skills

Product development

Statistical analysis

Quality tools

Auditing

Education

Bachelor's degree in Mechanical Engineering

Tools

ISO 13485

Quality tools (FMEA, SPC)

Job description

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.