Manufacturing Engineer II
Core
Control manufacturing processes, reduce defects, and enhance productivity for cardiovascular medical device solutions.
Role type
Manufacturing Engineer II (Medical Devices)
Builds
Cardiovascular medical device components and assembly processes
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lean, Six Sigma, Minitab, statistical analysis, FDA/QSR/ISO regulations, adhesive dispensing processes, root cause investigation, process capability studies, design of experiments
Preferred skills
SAP, cleanroom environment experience, advanced degree in engineering
Technologies
Minitab, SAP, X-ray, CT-scan, vision systems
Responsibilities
Control manufacturing processes while reducing defects and enhancing productivity; Use Lean and Six Sigma tools to analyze process trend data; Identify opportunities for process and yield improvement projects; Qualify and optimize processes and tooling via IQ/OQ/PQ, Gage R&R studies, and designs of experiments; Develop and maintain process documentation including assembly procedures, test procedures, BOMS, and process FMEAs; Conduct root cause investigations including product teardowns and X-ray or CT-scan analysis; Apply working knowledge of dispensing processes with adhesives such as Loctite and Epo-tek.
Seniority
Mid-level, hands-on IC
