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Intuitive Surgical, Inc.

Quality Assurance Associate Engineer

Intuitive Surgical, Inc. - Sunnyvale, CA

Job Description:

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

Primary Function of Position

The Quality Engineering 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 all da Vinci Surgical System product lines, including system platforms, endoscopic instrumentation, and supporting accessories. The Quality Assurance Associate Engineer will work with a team of dedicated individuals within the Development and Sustaining Engineering teams to:

Assure quality of new designs 

Identify quality issues related to ISI product, including instruments, accessories, and software subsystems and hardware 

Drive resolution of product quality issues through data analysis, reporting, and change advocacy 

The successful candidate will become a subject matter expert in customer use of ISI product, failure modes, and use of debug tools. This individual will be recognized cross-functionally as a “super user” who is expert in identifying areas of substandard product performance and successfully advocating design improvements to cross-functional engineering and management teams. The candidate must value shared responsibility and celebrate shared success, while forging strong relationships through collaboration with both teammates and internal customers. Roles & Responsibilities

PROTOCOL EXECUTION & REPORTING

Plans and directs creation of quality assurance processes and procedures, test methods, and fixtures for clinical simulation utilizing clinical and engineering knowledge 

Designs, develops and executes test protocols for clinically-based surgical simulation, automated testing, and functional verification 

Participate in the product development lifecycle, including the design review process. Review design documentation and UI prototypes to assess usability

Responsible for learning the elements of the SW build process to effectively execute, monitor and troubleshoot as necessary 

Evaluates instrument designs using measurement devices and inspection tools 

Identifies, reproduces, and escalates new or persistent software or hardware related failure modes to management and appropriate Engineering teams 

Troubleshoots, diagnoses, and documents all findings in the ISI bug-tracking database 

Complete documentation of test protocols, results and reports 

DATA ANALYSIS

Analyzes, trends, and publishes quality and reliability data 

Analyze test data, identify non-conformance trends, generate concise executive summaries, and recommend design improvements 

Develop SW scripts in Python or SQL for analyzing quality and reliability data 

Recommends enhancements related to quality, usability, or reliability to design teams, while representing patient, customer, and field service engineering needs 

Identifies and communicates substandard product performance or inadequate implementation of product requirements to engineering and management 

LABORATORY MAINTENANCE

Stocks, organizes, and otherwise maintains clinical simulation lab, ensuring adequate supply of test articles and other equipment or material 

Other Responsibilities:

Represents department cross-functionally in meetings that may include engineers, management, and external personnel 

Releases process and document changes through engineering change orders and deviations using ISI change control process 

Participate in process improvement activities as needed. 

Maintain transparency across the department and collaborate with other team members to work effectively.

Escalates to direct management all quality issues that could impact patient safety or surgical efficacy 

Ensures successful, on-time completion of department projects; communicates constraints to direct management when successful project completion is at risk 

Performs a broad variety of tasks in support of product and process design as assigned by department management 

Complies with company Department and Standard Operating Procedures 

Skill & Job Requirements

Required:

Bachelor's degree in Engineering or Life Sciences and one year of similar experience or Master’s degree in Engineering or Life Sciences 

Demonstrated understanding of or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820 and ISO 13485 

Demonstrated understanding of or aptitude to understand product development lifecycles, design change and document change control, process verification and validation methodologies, production process control methodologies in a medical device environment 

Demonstrated ability to be a quick learner and understand complex products and processes 

Exceptional analytical, problem-solving, and root-cause analysis skills 

Change agent with energy, passion, and enthusiasm to drive change 

Excellent verbal communication and writing skills in the context of reports, business correspondence, procedures 

Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others 

Demonstrated ability to work independently and with minimal supervision, multi-task, and handle tasks with competing priorities effectively 

Strong computer skills and experience with Windows operating system and Microsoft Office 

Preferred:

Relevant experience in a medical device company 

Demonstrated interest in medical devices, anatomy, surgery, and the medical field 

Experience with Agile/ACCS and SAP or other electronic documentation systems

We are an AA/EEO/Veterans/Disabled employer. #LI-ZL1

7 days 3 hours ago

Intuitive Surgical, Inc.

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Quality Assurance Associate Engineer Intuitive Surgical, Inc. - Sunnyvale, CA, United States

   

Location: Sunnyvale, CA

Company Profile:
The idea of surgical robotics was little more than a curiosity until 1999, the year Intuitive Surgical introduced the da Vinci® Surgical System. Today, Intuitive Surgical is the global leader in the rapidly emerging field of robotic-assisted minimally invasive surgery. Since its inception, the company has consistently provided surgeons and hospitals with the tools needed to improve clinical outcomes and to help patients return to active and productive lives. - See more at: http://www.intuitivesurgical.com/company/#sthash.g55v5yPr.dpuf