Manufacturing Process Engineer II — NPI & Validation

Jabil; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

Jabil in Singapore is seeking an Advanced Manufacturing Engineer to own assigned manufacturing processes, drive yield improvement, support NPI and manufacturing transfer, and lead validation activities for medical device and IVD products.

You will apply ISO 13485 and FDA 21 CFR Part 820 in daily engineering work, perform Gauge R&R and process capability analyses, manage change control and CAPA, and contribute to regulatory readiness and internal audits.

Qualifications

• Bachelor degree in Mechanical, Manufacturing, Industrial, Biomedical, Mechatronics or related Engineering.
• 3–5 years of manufacturing, process or industrial engineering experience.
• 2+ years of medical device, healthcare or IVD manufacturing experience preferred.
• Experience supporting NPI transfer and validation activities.

Responsibilities

• Develop, optimize and sustain manufacturing processes for assigned product lines.
• Lead value stream mapping, DMAIC, Kaizen, waste elimination and OEE improvement activities.
• Own IQ/OQ/PQ activities for assigned equipment, processes or production areas.
• Apply ISO 13485 and FDA 21 CFR Part 820 requirements in daily engineering work.
• Support processes involving fluidics assemblies, optics modules, motion control systems, reagent handling and environmental control requirements.

Skills

Lean manufacturing

Process optimization

Validation methods (IQ/OQ/PQ)

Risk assessment & FMEA

Education

Bachelor Degree in Mechanical, Manufacturing, Industrial, Biomedical, Mechatronics or related Engineering

Tools

Gauge R&R

Process capability analysis

CAPA

DMAIC

Job description

Jabil in Singapore is seeking an Advanced Manufacturing Engineer to own assigned manufacturing processes, drive yield improvement, support NPI and manufacturing transfer, and lead validation activities for medical device and IVD products.

You will apply ISO 13485 and FDA 21 CFR Part 820 in daily engineering work, perform Gauge R&R and process capability analyses, manage change control and CAPA, and contribute to regulatory readiness and internal audits.