Manufacturing Engineer - Systems
Core
Entry-level manufacturing engineer supporting multiple manufacturing lines for mature and new instruments and accessories for the Ion platform, leading line transfers and process improvements.
Role type
Entry-level manufacturing engineer (medical devices)
Builds
Ion platform instruments and accessories
Domain
Medical device manufacturing (robotic surgery)
Required skills
mechanical CAD (SolidWorks), component manufacturing processes (machining, injection molding, MIM, stamping, coining, extrusion), process/equipment qualifications (IQ/OQ/PQ/PPQ), project management, troubleshooting electromechanical equipment, Design for Manufacturing/Assembly (DFX), GMP compliance, root cause analysis
Preferred skills
mechanical design and analysis (statics, dynamics, kinematics, strength of materials, stress analysis), Design Control processes for medical devices, clinical applications of surgical instruments
Technologies
SolidWorks
Responsibilities
Lead manufacturing line transfer projects and project management across multiple functions and plants; procure, assemble, and qualify custom mechanical and electromechanical equipment; improve equipment documentation and design; develop and transfer knowledge to new engineers and assemblers; troubleshoot electromechanical equipment problems; establish communication with production teams; manage product reliability improvements; identify, design, qualify, document, and introduce assembly/test fixtures; improve process flows for reliability, efficiency, capacity, cost, and safety; execute and mentor others in manufacturing process validations and FMEAs; provide DFX input; manage manufacturing strategy and production capability; maintain compliance with medical device quality systems; provide technical support for failure analyses.
Seniority
Entry-level, hands-on IC