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Quality Assurance Associate Engineer

Intuitive Surgical

Intuitive Surgical

Quality Assurance
Sunnyvale, CA, USA
Posted on Thursday, July 4, 2024

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

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

Qualifications

SKILL & JOB REQUIREMENTS

Required

  • Minimum 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 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

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.