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Intuitive Surgical

Builds robots for minimally invasive surgery

Manufacturing Engineer

Manufacturing EngineeringConfirmed live in the last 24 hours
Full-timeSunnyvale, CA, USA

About the Job

Requirements

  • Excellent organizational skills and the ability to manage multiple fast-paced assignments simultaneously.
  • Ability to communicate effectively and professionally across technical disciplines and cultures with stakeholders, including management, peers, customers, and suppliers.
  • Ability to solve complex technical problems with equipment and/or manufacturing processes.
  • A Bachelor of Science degree in an engineering discipline is required.

Responsibilities

  • Contribute technical manufacturing, equipment design, and project management skills to a manufacturing engineering team creating precision instruments for minimally invasive robotic surgery.
  • Participate in the manufacturing engineering organization to refine electro-mechanical components, assemblies, process documentation, tooling, and test methods to improve efficacy, reliability, manufacturability, and cost.
  • Contribute to a collaborative team focused on continuous improvement.
  • Employ Design for Manufacturing/Assembly (DFx) to develop optimal product architecture in terms of reliability, quality, and cost.
  • Specify, design, document, and procure equipment necessary to perform each process step.
  • Plan, budget, and provide production equipment necessary to meet manufacturing capacity requirements.
  • Define lean manufacturing process flows to maximize production efficiency.
  • Author process failure mode and effects analyses (FMEAs) to identify and address potential manufacturing defects and minimize risks to patient safety.
  • Validate manufacturing equipment and processes to ensure efficacy and compliance with applicable requirements.
  • Maintain and improve production quality, yield, cost, and capacity.
  • Maintain compliance with the medical device quality system, including corrective action closure, discrepant material disposition, and Engineering Change Order (ECO) implementation.
  • Evaluate and help select suppliers for mechanical parts when required.
  • Help resolve supplier quality issues.
  • Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness.
  • Address line support issues as they arise, and document and report variances, problems, issues, or concerns related to the manufacturing process.
  • Provide production personnel with expectations and regular performance feedback in the production process.
  • Understand, train personnel, and enforce strict adherence to applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System.
  • Maintain up-to-date and accessible training records for MPIs and Quality System documents.
  • Assist in setting and attaining quarterly and annual production goals.
  • Learn and enforce company safety policies and practices.
  • Participate in quality improvement initiatives and provide feedback to identify root causes and solve problems.

Desired Qualifications

  • A Master of Science degree in an engineering discipline is preferred.
  • 1–3 years of experience in new product introduction (NPI), manufacturing, or design engineering supporting mid- to high-volume complex mechanism manufacturing.
  • Knowledge of manufacturing processes such as machining, injection molding, metal injection molding (MIM), crimping, welding, soldering, or joining with adhesives.
  • Quantitative process development skills in process FMEA, tolerance analysis, design of experiments (DoE), statistical process control (SPC), gage repeatability and reproducibility (GR&R), and process capability index (CpK).
  • Experience with mechanical computer-aided design (CAD) software such as SolidWorks and product lifecycle management (PLM) software such as Agile.
  • Prior experience with design control processes for medical devices.
  • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment.

About the Company

Intuitive Surgical

Builds robots for minimally invasive surgery

Intuitive Surgical makes da Vinci robots that let surgeons operate through a few small incisions, and Ion, a robot that reaches deep into the lungs to take tissue samples. In 2000, da Vinci became the first robotic system cleared by the FDA for general laparoscopic surgery, meaning keyhole operations in the abdomen. A surgeon sits at a nearby console and steers robotic arms holding a 3D camera and wristed instruments, which turn hand movements into smaller, steadier motions. Hospitals buy or lease the robots, then keep paying for the instruments used in each operation and for service. Intuitive was founded in 1995 to commercialize robotic surgery research from SRI International and is based in Sunnyvale, California.

Company size
10,001+
Company stage
IPO
Headquarters
Sunnyvale, CA
Founded
1995

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