Senior Manufacturing Engineer
Core
Design and develop manufacturing processes, tooling, and fixtures to meet production schedules while enhancing productivity and product quality for structural heart devices.
Role type
Senior Manufacturing Engineer
Builds
Production equipment, tooling, fixtures, and machinery 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
Project management, Process FMEA, Process Validation, Lean manufacturing, Tooling design, Cross-functional coordination, FDA compliance, Technical mentorship
Preferred skills
Six Sigma certification, International manufacturing experience, Medical device experience
Technologies
Lean manufacturing concepts, FDA regulations, QMS, EMS
Responsibilities
Manage projects for production equipment and process improvements; Conduct Process FMEAs and Process Validations; Improve product quality, labor efficiency, and throughput; Coordinate design, procurement, build, and debug of tooling; Drive projects with cross-functional teams
Seniority
Senior, hands-on IC