Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200218
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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:
The New Product Verification Department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The department plays a vital role in product and process quality, in new product development and production, and in the quality of da Vinci Surgical System product lines, including endoscopic instrumentation, and supporting accessories. The Senior Test Engineer will work with a team of dedicated individuals within New Product Development and New Product Verification to assure quality of new designs; to identify issues related to new designs and processes, and to work with other Test Engineers to develop and improve harmonized test methods.
Test Fixture Development
• Designs test fixtures and other test aids needed to perform Design Verification and Life/Reliabilty tests• Identifies processes and test methods that could benefit from new or updated fixture designs• Works with Test and Design Engineers to develop concepts and approaches to fixture designs• Responsible for documentation of fixtures utilizing SolidWorks; release of drawings into the document control system
Test Protocol Develpment
• Develops high level test plans for instrument, accessories, endoluminal, and vision projects• Generates test protocols for Design Verification and Life/Reliabilty tests• Works with Test and Design Engineers to develop test methods needed to ensure design requirements are sufficiently verified• Takes ownership of protocols to get them submitted and released through the documentation control system
Protocol Execution & Reporting
• Executes test protocols for clinically-based surgical simulation and automated testing utilizing da Vinci Surgical Systems and other test equipment• Identifies and reports problems that arise during feasibility and design verification testing, and escalates new or persistent failure modes to appropriate engineering teams• Analyzes test data, identify non-conformance trends, generate concise executive summaries, and recommend design improvements• Provides documentation to the cognizant Test/Design Engineer that clearly indicates the results of product testing• Generates reports that summarize all the test activities for a given product test cycle
Qualifications• Ensures successful, on-time completion of department projects; communicates constraints to direct management and/or cross functional team when successful project completion is at risk• Contributes to the strategy for reliability assessment and verification of robotic surgical instruments and/or endoscopes• Performs a broad variety of tasks in support of product verification and test process design as assigned by department management• Mentor and develop other test engineers skill-sets along with the development teams in an effort to drive the testing methodology deep into the earliest stages of product development• Complies with company Department and Standard Operating Procedures
• Education and/or Experience: Minimum of 8 years experience working in an engineering or research team environment. Bachelor’s Degree in an engineering discipline is required or commensurate experience. Mechanical engineering aptitude and an interest in robotics and medical device.
• Language Skills: Ability to read, write and understand English. Minimum of 5 years writing and executing effective test plans and protocol development. Ability to effectively present information in one-on-one and small group situations to other employees, supervisors, or engineers.
• Technical Skills: Experience testing hardware devices, especially in mechanical, robotic systems or endoscopes. Familiarity with equipment needed to perform typical performance measurements on electro-mechanical systems. Experience in medical device verification and validation testing of new products, and experience writing and/or interpreting product requirements into product specifications & tests to support regulatory submittals. Experience with automated testing tools (using and/or developing) preferred. An in-depth knowledge of failure mode root cause analysis and Weibull distribution statistical techniques. Experience with Medical Design Control processes is a plus.
• Reasoning Ability: Ability to apply commonsense understanding to carry out instructions. Ability to report quality issues. Ability to suggest process improvements, especially those involving test fixturing. Must be a quick learner with the ability understand complex products and processes.
• Computer skills: Ability to use personal computers as part of daily work. Ability to use on-line documentation.
• Other skills and abilities: Ability to work in a team environment. Ability to work independently and with minimal supervision. Ability to multitask, and handle tasks with competing priorities effectively. Ability to work with biological samples, including blood, tissue and organs.
• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
We are an AA/EEO/Veterans/Disabled employer.