全职 Process - Manufacturing Engineer III (IVD - Medical Device) 工作, 薪水, Jabil 公司招聘中 - Ricebowl

Position Summary

Acts as technical authority for manufacturing processes, technology transfer, process validation, equipment strategy and operational excellence for medical device and IVD manufacturing operations.

Technical Requirements

Manufacturing Strategy

• Define end-to-end manufacturing architecture, production scaling strategy and capacity planning approach.
• Lead technology transfer, manufacturing readiness and process standardization for new or transferred products.
• Develop automation strategy and evaluate advanced manufacturing technologies.
  
  

Advanced Technical Skills

• Lead complex root cause analysis using structured problem-solving methods.
• Apply SPC, DOE, process simulation, operations research and business case analysis.
• Drive high-impact improvement projects involving cost, quality, output, reliability and manufacturability.
  
  

Validation Leadership

• Define validation master strategy and approve IQ/OQ/PQ approach.
• Lead process validation strategy, equipment qualification strategy and validation risk assessment.
• Prepare the site for customer audits, ISO audits, FDA readiness reviews and regulatory inspections.
  
  

Medical Device Regulatory Expertise

• Serve as SME for ISO 13485, FDA inspection readiness, MDSAP awareness, design transfer and process validation expectations.
• Review change control impact, CAPA effectiveness, risk assessment and technical file support needs.
  
  

IVD Manufacturing Expertise

• Lead manufacturing readiness for hematology systems, urinalysis analyzers, immunoassay platforms and molecular diagnostic instruments.
• Provide technical direction for automated sample handling, precision dispensing, optical measurement, fluidics and motion control processes.
  
  

Leadership and Customer Interface

• Coach engineers and technicians, lead cross-functional problem solving and represent manufacturing engineering in customer technical reviews.
• Support RFQ, capacity model, line design, capital planning and transfer execution.
  
  

Education And Experience

• Bachelor Degree in Engineering; advanced degree is 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.
  
  

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