Medical Device Process Engineer II – NPI & Validation

Jabil; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

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

You will apply ISO 13485 and FDA 21 CFR 820 daily, lead lean initiatives, perform CP/DFM reviews, and collaborate across teams to ensure quality and regulatory readiness.

Qualifications

• Bachelor degree in engineering plus 3–5 years in manufacturing/industrial engineering.
• Experience in medical device/IVD manufacturing preferred.
• Experience supporting NPI transfer and validation activities.
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 is a plus.

Responsibilities

• Owns assigned manufacturing processes, drives yield improvement, supports NPI and manufacturing transfer, and leads validation activities for medical device and IVD products.
• 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.
• Participate in internal audits, customer audits and regulatory readiness activities.

Skills

Manufacturing processes

Lean & CI

Validation

Regulatory compliance

NPI transfer

Education

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

Job description

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

You will apply ISO 13485 and FDA 21 CFR 820 daily, lead lean initiatives, perform CP/DFM reviews, and collaborate across teams to ensure quality and regulatory readiness.