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 device manufacturing processes and production readiness
Domain
Medical device manufacturing / Healthcare technology
Required skills
Process qualification, Process validation, Statistical Process Control (SPC), Root cause analysis, Cross-functional collaboration, Engineering documentation, Process optimization, Regulatory compliance knowledge
Preferred skills
Machine vision systems, Automated inspection technologies, Supplier qualification, Lean Manufacturing, Six Sigma, Process standardization
Technologies
Machine vision, Automation solutions, Inspection systems
Responsibilities
Lead manufacturing process qualification, validation, and verification activities; Develop and optimize manufacturing processes for quality and throughput; 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; Support implementation of manufacturing technologies and automation; Create and maintain engineering documentation per regulatory requirements.
Seniority
Mid-level, hands-on IC