Manufacturing Engineer - Systems

Intuitive•Sunnyvale, CA

About The Position

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here. Primary Function of Position This Manufacturing-Mechanical Engineer (Manufacturing Engineer) position reports to a team responsible for one of the primary devices of the Da Vinci Multi Port Surgical System. In this position, the Manufacturing Engineer utilizes their 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.

Requirements

4 yr. degree in Mechanical Engineering.
3+ years experience as design or manufacturing engineer supporting product with significant mechanical content
Understanding of manufacturing processes including injection molding, machining, stamping and Process Engineering capability
Working knowledge of mechanical assembly, testing, and inspection processes.
Solid modeling/CAD experience (SolidWorks preferred)
Problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments
Excellent communication, organization, follow-up and documentation skills
Comfortable interacting with technicians, engineers, and management all on a regular basis
Technical skills in prototyping, tooling development and troubleshooting
ISO13485 or experience in medical device manufacturing environment

Nice To Haves

Electromechanical new product development experience preferred
Machine tool experience a plus

Responsibilities

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, supplying product and process DfX (Manufacturing, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
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.
Supports 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 implementation using tools such as 8D, DMAIC, 5-Why, Fishbones, etc..
Committed to delivering top tier manufacturing processes for new products. This includes developing and driving project milestones and schedules, resolving manufacturability issues and root cause analysis, to improvement throughput, yield and efficiency.
CAD skillset with vision for electro-mechanical assembly critique and for fixture creation.
Designs, document, assemble, implement fixtures and equipment.
Provides product and process DFA (Design for Assembly) input to Product Development Engineering to focus on manufacturability and reduce variation.
Supports repeatable and efficient “low-volume” manufacturing assembly line, specifying and/or refining BOMs, work flow processes and detailed work instructions.
Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions and ECO/NCO/MCO writing, reviewing and implementation.
Provides technical support with analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
Participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.
Strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.