Dialysis Device 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

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.