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Quality Assurance Associate Engineer

Company: Intuitive
Location: Sunnyvale
Posted on: May 28, 2023

Job Description:

Job DescriptionPRIMARY 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 advocacyThe 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 reportsData 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 managementLaboratory Maintenance
        • Stocks, organizes, and otherwise maintains clinical simulation lab, ensuring adequate supply of test articles and other equipment or materialOther 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 ProceduresSKILL & JOB REQUIREMENTS Required
            • Bachelor's degree in Engineering/Life Sciences and one year of similar experience or Master's degree in Engineering/Life Sciences. Candidates without a degree, but with commensurate experience will be considered (minimum of four years work experience).
            • 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 OfficePreferred
              • 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

Keywords: Intuitive, Sunnyvale , Quality Assurance Associate Engineer, Engineering , Sunnyvale, California

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