IVD Process Engineer - Medical Devices & NPI Validation

JABIL CIRCUIT (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Jabil Circuit (Singapore) PTE. LTD. is seeking an experienced Manufacturing Engineer to own assigned processes, drive yield improvements, and support NPI transfers and validation for medical device products.

You will lead IQ/OQ/PQ activities, perform capability analyses, and participate in audits to ensure regulatory readiness. Strong background in ISO 13485 and FDA-like controls is preferred.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, Mechatronics, or related Engineering.
• 3 to 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

• Owns assigned manufacturing processes, drives yield improvement, supports NPI and manufacturing transfer, and leads validation activities for medical device and IVD products.
• Lead IQ/OQ/PQ validation activities for equipment, processes, or production areas.
• Perform Gauge R&R, process capability analysis, risk assessments, and FMEA updates.
• Participate in internal audits, customer audits, and regulatory readiness activities.
• Support change control, CAPA, deviation management, traceability, and DHR requirements.

Skills

Process optimization

DMAIC

Kaizen

OEE improvement

Data-driven decisions

Education

Bachelor's degree in Mechanical/ Manufacturing/ Industrial Engineering

Tools

Gauge R&R

Process capability analysis

Job description

Jabil Circuit (Singapore) PTE. LTD. is seeking an experienced Manufacturing Engineer to own assigned processes, drive yield improvements, and support NPI transfers and validation for medical device products.

You will lead IQ/OQ/PQ activities, perform capability analyses, and participate in audits to ensure regulatory readiness. Strong background in ISO 13485 and FDA-like controls is preferred.