Engineer II, Manufacturing
Core
Optimize manufacturing processes and validate equipment/tools for medical device production, ensuring compliance and seamless knowledge transfer to production teams.
Role type
Manufacturing Engineer II (Medical Devices)
Builds
Manufacturing processes, validated equipment/tools, and compliance documentation for cardiovascular medical devices.
Domain
Medical Devices / Manufacturing Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering methods (Six Sigma, LEAN), experimental design and validation, CAPA and non-conformance resolution, project planning and risk analysis, technician training and oversight, CAD (preferred), statistical analysis, FDA regulations knowledge
Preferred skills
MS Project, lab/industrial equipment operation, problem-solving, organizational and critical thinking, vendor and stakeholder management
Technologies
MS Office Suite, MS Project, CAD
Responsibilities
Optimize manufacturing processes using engineering methods; develop and execute experiments to qualify/validate processes; analyze and resolve manufacturing/compliance issues; create training and documentation materials; establish project plans and manage deliverables; oversee manufacturing support tasks and instruct technicians
Seniority
Mid-level, hands-on IC
