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Associate Validation Engineer

Job Description

Job: Engineering
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 200352


Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and
decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position: 

Intuitive Surgical designs and manufactures highly complex systems for use in robotic surgery. These systems employ a combination of reusable surgical instruments and single use accessories for each surgical procedure. After each procedure it is crucial that reprocessing of reusable instruments and endoluminal devices be conducted in accordance with established guidelines in order to ensure patient safety. The Device Reprocessing & Sterilization department is responsible for the definition, implementation, and communication of these guidelines to development teams. The primary function for the Associate Validation Engineer is to support new product designs and updates to existing products so that they are compatible with the required reprocessing and sterilization standards. The primary responsibility is to support testing plans of da Vinci instruments and endoluminal devices, applying cleaning, disinfection and sterilization concepts. This role will interface with validation engineers for guidance, as well as, design engineers to help define and execute test plans for various platforms in cleaning, disinfection and sterilization. 

The successful candidate must excel in a high-energy, high organizational skills, able to work in small focused team environment to support reprocessing solutions from early development to implementation with a high commitment to quality. The ability to learn rapidly and perform in a high pace environment are essential. A strong sense of shared responsibility is required, as is the ability to make work fun and interesting. Supporting this role will be a technical and management team that knows and cares about what you are doing, and wants you to succeed.

Roles and Responsibilities:

• Supports execution of device reprocessing test plans specifically in the area of reusable medical devices
• With guidance, adapts existing protocols as required to document cleaning, disinfection and sterilization testing
• Organizes and executes cleaning validation, disinfection and sterilization testing. Collaborates with validation engineers to support project deliverables
• With guidance, drafts and releases testing reports in life management control system (Agile)
• Supports cleaning and sterilization validation activities with external organizations and laboratories, coordinating interactions between the various project teams and the external labs
• Follows standard procedures for cleaning, disinfection and sterilization (internally/externally)
• Supports activities related to installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) in the Cleaning & Sterilization lab as required.
• Supports Engineering, New Product Development and Manufacturing for resolution of reprocessing and sterilization issues
• Under guidance, performs additional cleaning, disinfection and sterilization studies to support responses to regulatory submissions
• Commits to continuous learning of applicable device reprocessing standards and regulations
• Builds stable working relationships internally/externally
• Other duties as assigned

Skill/Job Requirements: 

• High School Diploma Required
• BS in Engineering or Biological Sciences is preferred or 3 yrs of medical devices experience (on-the job training)
• Hands-on engineering skills with the proven ability to work well in a team environment and drive results
• High level knowledge of design control systems and medical device regulations
• Great organizational skills and ability to execute complex projects
• Good written and oral communications. Listens to the viewpoint of others.
• Good working knowledge of MS Office.
• Self-started with ability to focus on the critical few tasks

We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.