Process / Manufacturing Engineer III (IVD / Medical Device)
Core
Technical authority for manufacturing processes, technology transfer, process validation, and operational excellence for medical device and IVD manufacturing operations.
Role type
Senior IC manufacturing/process engineer (medical device & IVD)
Builds
End-to-end manufacturing architecture, production scaling strategies, and automated diagnostic instrument lines
Domain
Medical devices & In Vitro Diagnostics (IVD)
Required skills
Manufacturing strategy, technology transfer, process validation (IQ/OQ/PQ), root cause analysis, SPC, DOE, process simulation, automation strategy, regulatory compliance (ISO 13485, FDA), change control, CAPA, risk assessment
Preferred skills
Advanced degree in engineering, 3+ years in medical device or IVD manufacturing, NPI ownership, customer-facing technical activities
Technologies
Hematology systems, urinalysis analyzers, immunoassay platforms, molecular diagnostic instruments, automated sample handling, precision dispensing, optical measurement, fluidics, motion control
Responsibilities
Define manufacturing architecture and capacity planning; lead technology transfer and process standardization; drive high-impact improvement projects for cost, quality, and reliability; prepare site for customer, ISO, and FDA audits; serve as SME for regulatory expectations; provide technical direction for automated diagnostic instrument processes; coach engineers and lead cross-functional problem solving
Seniority
Senior, hands-on IC