Manufacturing Engineer - Systems

Intuitive•Sunnyvale, CA

About The Position

Intuitive is seeking an entry-level Manufacturing Engineer to support multiple manufacturing lines for mature and new instruments and accessories for the Ion platform. The engineer will support existing production lines, recommend and implement improved manufacturing processes, and lead manufacturing line transfers. The role involves collaboration across Quality, Design, and Manufacturing teams in the United States and Mexico. The position leads manufacturing line transfer projects, including coordinating schedules across functions and plants, procuring and qualifying custom equipment, improving equipment documentation and design, and transferring process knowledge remotely. It also supports production lines through reliability improvements, fixture and equipment development, process-flow optimization, validation activities, design-for-manufacturing input, manufacturing strategy, failure analysis, and compliance with medical-device quality-system requirements. The role requires effective communication across functions and levels, strong organization and analytical problem solving, and the ability to manage multiple fast-paced projects. Travel, including international travel, is required at 25%.

Requirements

Bachelor of Science degree in an engineering discipline.
Strong technical problem-solving and analytical skills.
Familiarity with component manufacturing processes such as machining, injection molding and MIM, stamping, coining, and extrusion.
Familiarity with mechanical CAD software, specifically SolidWorks.
Familiarity with process and equipment qualifications, including IQ/OQ/PQ/PPQ.
Strong organizational skills and ability to work on several fast-paced projects simultaneously.
Ability to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers, and external suppliers.
Ability to travel 25%, including internationally.

Nice To Haves

Master's degree.
Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis.
Prior experience with Design Control processes for medical devices, clinical applications of surgical instruments, or automated equipment design.

Responsibilities

Lead manufacturing line transfer projects, including project management and schedule monitoring across multiple functions and two plants.
Procure, assemble, and qualify custom mechanical and electromechanical equipment.
Improve equipment documentation and design for continuous improvement and future transfers.
Develop detailed knowledge of manufacturing processes and transfer knowledge remotely to new engineers and assemblers.
Troubleshoot electromechanical equipment, collaborating with third-party equipment makers as needed.
Support multiple Ion manufacturing lines and maintain regular communication with production teams about short- and long-term support needs.
Manage product reliability improvements from concept through implementation.
Identify, design, qualify, document, and introduce assembly and test fixtures and equipment.
Improve manufacturing process flows to optimize reliability, efficiency, capacity, cost, and technician safety.
Execute and mentor others in manufacturing process validations, process FMEAs, and other Master Validation Plan activities.
Provide Design for Manufacturing/Assembly input and lead manufacturability improvements.
Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders.
Maintain compliance with the medical-device quality system, including corrective action closure, discrepant material disposition, and Engineering Change Order implementation.
Provide technical support for failure analyses and root-cause investigations of product failures.
Contribute to group and individual objectives, priorities, metrics, and progress communication.
Provide resource budget estimates for product and process improvements, tooling development, and testing.
Work with Quality and Regulatory to ensure compliance with appropriate GMP, DHF, and DHR guidelines per FDA requirements.