Manufacturing Engineer II
Core
Develop, qualify, and sustain manufacturing processes for medical device production to ensure product quality, operational efficiency, and regulatory compliance.
Role type
Manufacturing Engineer II (Process Qualification & Validation)
Builds
Medical devices and production processes
Domain
Medical device manufacturing / Regulated industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process qualification, process validation, Statistical Process Control (SPC), root cause analysis, cross-functional collaboration, engineering documentation, risk reduction
Preferred skills
machine vision systems, automated inspection technologies, supplier qualification, Lean Manufacturing, Six Sigma, process standardization
Technologies
inspection systems, automation solutions, machine vision applications
Responsibilities
Lead manufacturing process qualification, validation, and verification activities; Develop, implement, and optimize manufacturing processes; Analyze process performance using SPC and data-driven methods; Drive investigation and corrective actions for manufacturing issues; Partner with Quality, Supply Chain, and R&D to execute improvement initiatives; Create and maintain engineering documentation and technical records.
Seniority
Mid-level, hands-on IC