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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