Manufacturing Engineer

NEXTKIDNEY SG PTE. LTD.; Singapore; On-site; SGD 50,000 - 85,000; Full time

Job summary

Nextkidney SG PTE. LTD. is seeking a Manufacturing Engineer in Singapore. You will design, implement and optimize manufacturing procedures and equipment to support a disciplined production environment.

Responsibilities include working with cross-functional teams to improve design for manufacturability, leading production changes, and validating processes under GMP/ISO-13485 regimes in a fast-growing medical device setting.

Qualifications

• Bachelor's degree in Biomedical/Manufacturing/Mechanical Engineering.
• 2–3 years manufacturing experience in regulated industry.
• Knowledge of GMP/ISO 13485 and validation protocols (IQ/OQ/PQ).

Responsibilities

• Design, implement and review manufacturing procedures and equipment.
• Improve product design for manufacturability and assembly.
• Lead engineering changes into production and manage validation tests.

Skills

Manufacturing engineering

Biomedical engineering

Lean manufacturing

GMP ISO 13485

Project management

Education

Bachelor's degree in biomedical / manufacturing / mechanical engineering

Tools

GMP/ISO 13485 processes

Process validation (IQ/OQ/PQ)

Supplier audits

Job description

About Us

Nextkidney is a leading medical technology company in the development of sorbent based portable hemodialysis device that is compact and light weight. It allows for low volume of 5L dialysate fluid per treatment instead of 25 to 30L. In Singapore, we are focused on the developing the dialysate regenerative device for use with the portable hemodialysis device.

Headquarters in Netherlands, the group comprises of a subsidiary in Lausanne, Switzerland and in Singapore. 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

Nextkidney SG is seeking dedicated and talented individuals with a proactive and positive 'can-do' attitude to join our team. We are looking to add a Manufacturing Engineer in Singapore team.

As a Manufacturing Engineer, you will be:

• Responsible for designing, implementing and reviewing the procedures and equipments involved in the manufacturing process, including researching automation techniques to maximize the efficiency or production lines and planning factory layouts or warehouses.
• Work with engineers to improve product design for ease of manufacturing and assembly.
• Lead the implementation of engineering changes into production.
• Manage projects using engineering principles and techniques.
• Manage and develop validation protocols (IQ/ OQ/ PQ), execute validation tests and document results accurately.
• Management of contract manufacturer and suppliers to ensure on time delivery and quality, including supplier's list.
• Responsible for the production line setup and equipment planning, define manufacturing line layout, sourcing for tooling, fixtures and equipment and CAPEX.
• Prepare and release manufacturing related documents in accordance with ISO 13485 requirements.
• Determines root cause and corrective action analysis for issues that arise during assembly and/or test of systems; provides failure analysis report and/or corrective/continuous improvement actions as required.
• Performs Process Failure Mode, Effects and Criticality Analysis when working with New Product Development.
• Ensure that the company's manufacturing processes are compliant with all government laws and regulations.
• Responsible for ramp-up, maintenance and improvement of manufacturing systems by identifying and implementing areas for improvement. Ensure product can be manufactured reliably and perform consistently in specified operating environments.
• Apply Lean manufacturing concept to minimise waste of material and labour. Proactively lead and participate in cost reduction, yield improvement activities.
• Review labour, material and other production costs along with reviewing schedules and future production requirements to assist management in decision making.
• Monitor and manage raw material and component inventory to support uninterrupted manufacturing operations.
• Lead physical inventory counts, cycle counts, and reconciliation of variances.
• Maintain warehouse layout, monitor medical device storage (e.g., temperature, humidity, segregation of materials).
• Stay updated with emerging trends, technologies, and medical device production regulations.

Requirements

• Bachelor's degree in biomedical / manufacturing / mechanical engineering or relevant field.
• 2 to 3 years' experience in manufacturing within a regulated industry.
• Knowledge of Medical or Life Science Instrument Manufacturing and exposure to GMP ISO 13485, protocols for validations and qualifications including IQ/OQ/PQ.
• Lean manufacturing certification is preferred.
• Experience with warehouse operations or inventory management.
• Experience in performing supplier audits and supporting supplier qualifications plus issuing and reviewing supplier non-conformances (SCARs)

Attributes

• Able to work independently
• Effective communicator
• Problem-solving abilities

Be part of the Nextkidney family!