Process / Manufacturing Engineer (IVD / Medical Device)

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

OUR COMPANY

• At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions.
• Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

POSITION SUMMARY

• Owns assigned manufacturing processes, drives yield improvement, supports NPI and manufacturing transfer, and leads validation activities for medical device and IVD products.

TECHNICAL REQUIREMENTS

Advanced Manufacturing Engineering

• Develop, optimize, and sustain manufacturing processes for assigned product lines.
• Support DFM reviews, assembly optimization, equipment qualification, and workstation design.
• Perform process capability studies and define improvement actions.

Lean and Continuous Improvement

• Lead value stream mapping, DMAIC, Kaizen, waste elimination, and OEE improvement activities.
• Drive cost reduction projects through process simplification, layout improvement, and equipment utilization.
• Use data-driven methods to improve line efficiency, yield, and production stability.

Validation Expertise

• Own IQ/OQ/PQ activities for assigned equipment, processes, or production areas.
• Perform Gauge R&R, process capability analysis, risk assessments, and FMEA updates.
• Prepare validation reports, process release evidence, and manufacturing readiness documentation.

Medical Device Compliance

• Apply ISO 13485 and FDA 21 CFR Part 820 requirements in daily engineering work.
• Support change control, CAPA, deviation management, traceability, and DHR requirements.
• Participate in internal audits, customer audits, and regulatory readiness activities.

IVD-Specific Knowledge

• Support processes involving fluidics assemblies, optics modules, motion control systems, reagent handling, and environmental control requirements.
• Troubleshoot process-related failures on IVD analyzers or medical device equipment.

KEY REQUIREMENTS

• 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.