Engineering Lead
Core
Lead engineering execution for healthcare and IVD manufacturing transfer programs, ensuring product qualification, process validation, and mass production release.
Role type
Senior Engineering Lead (Manufacturing Transfer & Validation)
Builds
Production lines, validated processes, and qualified manufacturing sites for medical devices
Domain
Healthcare / Medical Devices / IVD Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing engineering, Process engineering, Test engineering, Validation strategy (IQ/OQ/PQ), Regulatory compliance (ISO 13485, FDA), Root cause analysis, PFMEA, SPC, DOE, Lean manufacturing, Cross-functional leadership, Program management
Preferred skills
IVD analyzer experience, Clinical diagnostic instrument transfer, FDA audit support, ISO 13485 auditor training, MDSAP knowledge, PMP, Lean Six Sigma
Technologies
Fluidics, Pumps, Valves, Reagent handling, Optics, Sensors, Motion control, Actuators, Analyzer integration, Production test systems
Responsibilities
Lead complete manufacturing transfer programs from customer to site, Establish engineering project plans and resource models, Own overall validation strategy and approve protocols, Direct process development and line setup, Direct test strategy and production test readiness, Ensure regulatory compliance and audit readiness, Lead and mentor engineering teams
Seniority
Senior, hands-on IC with program leadership
