Primary Function of 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.
Roles & 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.
- 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.
- 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.
- Evaluate performance, re-design, upgrade, and optimize existing production equipment.
- Determine troubleshooting, maintenance, consumables, spares, and calibration procedures for each piece of equipment and train relevant personnel to perform and manage them.
- 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.
- Provide equipment-related technical support to on-going production operations including maintenance, spare parts, repairs, and documentation of support activities.
- Develop and manage supplier and factory acceptance test protocols.
- Perform engineering studies to characterize equipment process windows.
- 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.
- 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.
- Organize and execute obsolescence plans.
- Travel to our production plant in Mexico to ensure technology transfer to Mexicali personnel. Occasionally travel domestically and internationally to suppliers.
- Provide mentoring and management for direct reports to assist with implementation of primary individual contributor tasks.
Skill/Job Requirements:
- Minimum BS Engineering with 5 years minimum related experience.
- Experience in the development of complex integrated equipment or products preferred.
- 3D CAD capability required, SolidWorks preferred.
- Great attitude, eager, willing/able to take initiative, works well with others in team environment.
- Track record developing high quality, reliable products.
- 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%.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
