Process / Manufacturing Engineer (IVD / Medical Device)

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.