Engineer II, Manufacturing, Equipment Maintenance
Core
Engineer II optimizing manufacturing processes, qualifying/validation testing, and resolving compliance issues for cardiovascular medical devices.
Role type
Manufacturing Engineering II (Equipment Maintenance & Process Validation)
Builds
Manufacturing processes, validated equipment/tools, compliance documentation
Domain
Medical Devices / Cardiovascular / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Six Sigma, LEAN, experimental design, protocol execution, CAPA management, project planning, technical design, equipment qualification
Preferred skills
CAD, statistical analysis, FDA regulations knowledge, MS Project, leadership
Technologies
MS Office Suite, MS Project, CAD
Responsibilities
Optimize/improve manufacturing processes using engineering methods; Develop and execute experiments to qualify/validate processes; Analyze and resolve complex Manufacturing and Compliance issues; Develop training and documentation materials; Lead project plans to ensure deliverables meet customer expectations; Oversee manufacturing support tasks and instruct technicians
Seniority
Mid-level, hands-on IC
