Manufacturing Engineer — Medical Devices, Lean & GMP

NEXTKIDNEY SG PTE. LTD.; Santo Niño 1st; On-site; PHP 2,941,000 - 4,412,000; Full time

Job summary

Nextkidney SG PTE. LTD. in Singapore is seeking a Manufacturing Engineer to design, implement and review manufacturing procedures and equipment. The role includes researching automation to maximize production line efficiency and ensuring regulatory compliance.

You will lead changes, manage validation protocols (IQ/OQ/PQ), coordinate with contract manufacturers and suppliers, and develop factory layouts with CAPEX planning. Lean improvements and cost-reduction are expected.

Qualifications

• 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)

Responsibilities

• Design, implement and review procedures and equipment involved in the manufacturing process, including researching automation techniques to improve efficiency.
• Lead the implementation of engineering changes into production.
• Manage projects using engineering principles and techniques.
• Develop and validate protocols (IQ/OQ/PQ) and document results.
• Oversee contract manufacturers and suppliers to ensure on-time delivery and quality.
• Plan manufacturing line layout, tooling, fixtures and CAPEX.
• Prepare and release manufacturing documents per ISO 13485.
• Perform root cause analysis and implement corrective actions.
• Contribute to Lean initiatives to reduce waste and cost.
• Monitor inventory and support uninterrupted operations.

Skills

Biomedical engineering

Manufacturing

Lean manufacturing

Problem-solving

Independent worker

Effective communicator

Education

Bachelor's degree in biomedical/manufacturing/mechanical engineering

Job description

Nextkidney SG PTE. LTD. in Singapore is seeking a Manufacturing Engineer to design, implement and review manufacturing procedures and equipment. The role includes researching automation to maximize production line efficiency and ensuring regulatory compliance.

You will lead changes, manage validation protocols (IQ/OQ/PQ), coordinate with contract manufacturers and suppliers, and develop factory layouts with CAPEX planning. Lean improvements and cost-reduction are expected.