Manufacturing Engineer II
Core
Design and develop manufacturing processes, tooling, and fixtures for structural heart devices to meet production schedules and enhance quality.
Role type
Manufacturing Engineer II (IC)
Builds
Manufacturing processes, tooling, fixtures, and production equipment for structural heart devices
Domain
Medical devices / Structural Heart
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process improvement, Lean manufacturing, Process FMEA, Process validation, Design for Manufacturability, Project management, Tooling design, Cross-functional coordination, FDA compliance, Technical mentorship
Preferred skills
Six Sigma certification, International manufacturing experience, Medical device experience, Enterprise/cross-division business unit experience
Technologies
Lean manufacturing concepts, FDA regulations, QMS, EMS
Responsibilities
Manage projects for new production equipment and process improvements; Conduct Process FMEAs and Process Validations; Improve product quality and throughput via Lean concepts; Coordinate design and build of tooling and machinery; Support Design for Manufacturability with Product Development; Provide technical mentorship to engineers and technicians.
Seniority
Mid-level, hands-on IC
