Process / Manufacturing Engineer II (IVD / Medical Device)

About the role

Jabil is looking for a Process / Manufacturing Engineer II focused on IVD and medical device products. The engineer owns assigned manufacturing processes, drives yield improvement, supports new product introduction (NPI) and manufacturing transfer, and leads validation activities.

Key responsibilities

• Develop, optimize and sustain manufacturing processes for assigned product lines, support DFM reviews, assembly optimization, equipment qualification and workstation design, and run process capability studies.
• Lead value stream mapping, DMAIC, Kaizen, waste elimination and OEE improvement, and drive cost reduction through process simplification, layout improvement and equipment utilization.
• Own IQ/OQ/PQ activities, perform gauge R&R, process capability analysis, risk assessment and FMEA updates, and prepare validation reports, process release evidence and manufacturing readiness documentation.
• Apply ISO 13485 and FDA 21 CFR Part 820 requirements, support change control, CAPA, deviation management, traceability and DHR, and take part in internal and customer audits.
• Support fluidics assemblies, optics modules, motion control systems, reagent handling and environmental control, and troubleshoot process failures on IVD analyzers and medical device equipment.

Required profile

• 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.