Manufacturing Equipment Engineer

Intuitive•Sunnyvale, CA

7d•$105,500 - $178,700•Onsite

About The Position

Participate in the specification, design, sourcing, construction, upgrade, sustaining, and maintenance of manufacturing and test equipment used to produce minimally invasive surgical robotic instruments and accessories. This manufacturing equipment will range in complexity from catalog process equipment to custom automated electromechanical systems. Processes include heat staking, ultrasonic welding, laser welding, leak testing, pressing, crimping, and tray sealing.

Requirements

BS Engineering with 3 years minimum related experience.
Experience in the development of complex integrated equipment or products preferred.
3D CAD capability required, SolidWorks, PTC Windchill preferred
Experience with PLM software, ECOs, BOM creation and management
Familiarity with PLC systems, sensors, and manufacturing equipment.
Great attitude, eagerness, willing/able to take initiative, works well with others in team environment.
Strong analytical skills including FMEA, tolerance analysis, and statistical methods.
Familiarity with regulated Quality Systems, especially medical device regulations, a plus.
Able to travel periodically up to 25%.

Responsibilities

Specify the requirements for, and manage the creation of, manufacturing equipment which can be designed and fabricated by third parties. Jointly develop custom tooling based on ISI’s product form factor.
Evaluate performance, re-design, upgrade, and optimize existing production equipment.
Design and build manufacturing tooling components which are deemed too proprietary or complex to develop out of house.
Duplicate existing manufacturing equipment including orders, inventory, assembly, installation, and validation in production.
Recommend and implement improvements to documentation, functionality, and assembly of equipment to optimize for cost, performance, consistency, and speed of delivery.
Qualify manufacturing equipment to ensure the fulfillment of all requirements including IQ/OQ/PQ validation and verification activities. Ability to create and execute quality documentation for internally and externally designed production equipment.
Develop and manage supplier and factory acceptance test protocols.
Develop production processes including automation parameters for electronic controls, pneumatics, laser welding, laser marking, heat staking, ultrasonic welding, crimping, pressing, thermoforming, tray sealing, and more.
Perform engineering studies to characterize equipment process windows.
Determine troubleshooting, maintenance, consumables, spares, and calibration procedures for each piece of equipment and train relevant personnel to perform and manage them.
Thoroughly document all aspects of the equipment, including its requirements, design, operation, and qualification in compliance with Good Manufacturing Processes (GMP).
Improve equipment quality and reliability using DFX, Six Sigma, SPC, Gauge R&R, and similar quality tools.
Provide equipment-related technical support to on-going production operations including maintenance, spare parts, repairs, and documentation of support activities.
Advocate techniques for world class equipment & tooling design for manufacturing, assembly, and product test.
Support product cost reductions derived from equipment and tooling used in manufacturing.
Travel to our production plant in Mexico to ensure technology transfer to Mexicali personnel. Occasionally travel domestically and internationally to suppliers.