Process / Manufacturing Engineer III (IVD / Medical Device)

About the role

Jabil is looking for a Process / Manufacturing Engineer III to act as technical authority for manufacturing processes, technology transfer, process validation, equipment strategy and operational excellence in medical device and IVD manufacturing operations.

Key responsibilities

• Define end-to-end manufacturing architecture, production scaling strategy and capacity planning, and lead technology transfer, manufacturing readiness and process standardization for new products
• Develop automation strategy and evaluate advanced manufacturing technologies
• Lead complex root cause analysis and drive improvement projects on cost, quality, output, reliability and manufacturability
• Apply SPC, DOE, process simulation, operations research and business case analysis
• Define validation master strategy, approve IQ/OQ/PQ approach and lead process validation, equipment qualification and validation risk assessment
• Prepare the site for customer audits, ISO audits, FDA readiness reviews and regulatory inspections
• Serve as subject matter expert for ISO 13485, FDA inspection readiness, MDSAP awareness, design transfer and process validation, and review change control, CAPA, risk assessment and technical file support
• Lead manufacturing readiness for hematology systems, urinalysis analyzers, immunoassay platforms and molecular diagnostic instruments, and guide automated sample handling, precision dispensing, optical measurement, fluidics and motion control
• Coach engineers and technicians, lead cross-functional problem solving and represent manufacturing engineering in customer technical reviews
• Support RFQ, capacity models, line design, capital planning and transfer execution

Required profile

• Bachelor's degree in Engineering; advanced degree preferred but not mandatory
• 5 to 8+ years of manufacturing, process or industrial engineering experience
• 3+ years of medical device or IVD manufacturing experience preferred
• Demonstrated ownership of NPI, validation, technology transfer and customer-facing technical activities

Required skills

• SPC, DOE, process simulation, operations research
• ISO 13485, FDA inspection readiness, MDSAP awareness
• Root cause analysis and validation leadership