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.
