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, and capacity planning for medical device and IVD products
Domain
Medical device manufacturing / In Vitro Diagnostics (IVD)
Required skills
Manufacturing strategy, technology transfer, process validation (IQ/OQ/PQ), root cause analysis, SPC, DOE, process simulation, operations research, cost/quality/output improvement, ISO 13485, FDA inspection readiness, MDSAP, NPI, automation strategy, fluidics, motion control
Preferred skills
Advanced degree in engineering, 3+ years medical device or IVD manufacturing experience, customer-facing technical activities
Technologies
SPC, DOE, process simulation, automated sample handling, precision dispensing, optical measurement, fluidics, motion control
Responsibilities
Define end-to-end manufacturing architecture and production scaling strategy; Lead technology transfer and process standardization; Drive high-impact improvement projects involving cost, quality, and output; Define validation master strategy and approve IQ/OQ/PQ approach; Serve as SME for ISO 13485, FDA inspection readiness, and MDSAP; Lead manufacturing readiness for hematology systems, urinalysis analyzers, immunoassay platforms, and molecular diagnostic instruments; Coach engineers and technicians and represent manufacturing engineering in customer technical reviews
Seniority
Senior, hands-on IC