Manufacturing Engineer II
Core
Support sustaining manufacturing lines to high-scale production, ensuring process robustness, quality, and regulatory compliance for medical devices.
Role type
Manufacturing Engineer II (Medical Devices)
Builds
Medical device assemblies and systems for cardiovascular, neuroscience, and surgical care
Domain
Healthcare technology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Master Validation (IQ/OQ/PQ), GD&T, mechanical drawing interpretation, risk management (pFMEA, dFMEA), FDA 21 CFR Part 820, ISO 13485, Engineering Change management, PLM tools, statistical process control, root cause analysis, equipment qualification, process optimization, shift operations oversight, documentation authoring, training delivery, cross-functional collaboration
Preferred skills
FDA 21 CFR Part 820, ISO 13485, Agile, PTC Windchill
Technologies
PTC Windchill, Agile
Responsibilities
Oversee shift operations to maintain continuous production; Author and maintain production documents and equipment protocols; Investigate and resolve non-conformances via root cause analysis; Partner with NPI teams to execute validation protocols; Design and optimize manufacturing processes and workflows; Monitor machinery performance and initiate corrective actions; Provide training to production teams
Seniority
Mid-level, hands-on IC