Senior NPI Manufacturing-Mechanical Engineer

Company Description

At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique. 

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.  

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care.

Job Description

Primary Scope of Position:

This Senior New Product Introduction Manufacturing-Mechanical Engineer (Senior NPI Engineer) position reports to the Manufacturing Engineering Manager for Da Vinci Single Port Surgical System’s Instrument products. In this position, the Senior NPI Engineer utilizes their in-depth manufacturing, equipment, and design knowledge to collaborate with design engineering to discover, define, develop, and validate new assembly and test equipment along with assembly process solutions.  Their primary focus is to develop assembly and test processes, establish engineering requirements, consider process risks, and identify solutions to guide development. Ultimately they implement and optimize assembly process equipment, fixturing, and test solutions.  They focus on opportunities for poka-yoke, DfX, semi-automated and automated solutions, and design for assembly opportunities to achieve optimal safety, reliability, serviceability, manufacturability, and cost. After production release, and as needed for current released products, they act as the “first line of defense” by providing sustaining support to the manufacturing line while driving continuous improvement of manufacturing processes, equipment, and maintenance procedures. They perform comprehensive failure analysis to identify root cause of emergent production issues, efficiently documenting, mitigating, and closing of non-conformances, and performing requalification of production equipment.

Roles and Responsibilities:

Technical Expertise

• Strong mechanical engineering skills with demonstrated proficiency in manual assembly techniques. Mechanical design experience is required.
• In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.
• Proven diverse capability to adapt and work with support teams on software, algorithms, electronics aspects of the device, and human interface needs.
• Proactively evaluates and challenges designs for technical merit, reliability, serviceability, and manufacturability while working with design partners to realize optimal outcomes.
• Provides a voice for the manufacturing process of Intuitive’s products.  Leads product and process DfX (Manufacturing, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
• Proven ability to identify and assess potential process risks and mitigations and maintain currency of process FMEA and other quality records.
• Own and drive continuous improvement of quality, throughput, and cost during development and after product market release.  Utilize analytical objective data and statistical analysis to inform and drive decisions.
• Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflows and detailed work instructions. This includes developing the process flow at the unit operation level, creating manufacturing process instructions (MPIs), and developing requirements for processes and test equipment.
• Responsible for the validation, qualification, and documentation of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ).
• Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions and change order creation, review, and implementation.
• Provides technical support for failure analysis of discrepant production components, assemblies, and field returns.  Leads investigations with a cross-functional team to identify root cause, determine mitigations, and drive imple