Manufacturing Engineer II
Core
Provides sustaining engineering and equipment support for commercialized medical device products, ensuring stable manufacturing performance, high product quality, and regulatory compliance.
Role type
Manufacturing Engineer II (Medical Devices)
Builds
Electro-mechanical insulin pumps and diabetes management systems
Domain
Medical device manufacturing / Diabetes technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, validation (IQ/OQ/PQ), change control, regulatory compliance (FDA QSR, ISO 13485), electro-mechanical troubleshooting, process improvement (Lean/Six Sigma), 3D modeling (SolidWorks/Pro/E), PLM systems
Preferred skills
Lean Manufacturing, Green/Black Belt certification, Design of Experiment, statistical analysis, process development, semi-automation with embedded software, Agile PLM, ERP/MES
Technologies
SolidWorks, Pro/E, PLM, ERP, MES
Responsibilities
Troubleshoot manufacturing, process, and equipment issues impacting yield, quality, or throughput; Lead root cause investigations (RCA) for complex electro-mechanical failures; Analyze manufacturing performance data and lead continuous improvement initiatives; Evaluate, procure, and support manufacturing equipment; Develop and Execute IQ/OQ/PQ validations; Manage engineering changes (ECOs) and update manufacturing documentation; Ensure compliance with FDA QSR and ISO 13485; Support supplier and lifecycle management for electro-mechanical components; Develop and deliver training to manufacturing personnel; Support R&D in transitioning new products to manufacturing; Collaborate with Quality on nonconformances, CAPAs, and audits; Partner with Supply Chain to resolve supplier-related issues; Evaluate and implement design or process changes to address field issues.
Seniority
Mid-level IC