Failure Analysis Engineer

Intuitive•Peachtree Corners, GA

18h

About The Position

The Failure Analysis Engineer uses their working knowledge of failure modes of da Vinci® products to work with technicians, FA engineers and clinical engineers to assess existing and potential failures within the Intuitive product lines. These products include instruments, accessories, robotic systems, vision systems, and other related features. Their primary focus is to assess how and why products in the market may have gaps between their expected and actual performance. Post Market Investigation supports data-driven product quality improvements that are focused on improving patient value by: Deeply understanding, documenting and disseminating How and Why products fail Ensuring consistency and accuracy of failure data Continuously building our knowledge base through cross-functional collaboration As Intuitive's da Vinci® Surgical System becomes adopted by an increasing population of hospitals, surgeons and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to analyze, monitor, and improve product and process. Intuitive seeks a strong contributor who can help perform failure analysis, identify key opportunities for product improvement, and help solve challenging problems. The ideal candidate possesses strong desire to ask the right questions, and is comfortable communicating the technical answers across multiple parts of the organization.

Requirements

A minimum of 4 years of experience in medical devices, engineering, or failure analysis.
Strong Troubleshooting mind set - an ability to methodically break down a system or process into subparts to identify failures and troubleshoot to a component level.
Knowledge of 8D problem solving, Fishbone Diagraming, and the Five Whys.
Proven ability to work in teams and to work cross-functionally.
Strong interpersonal and communication skills.
Passionate about our mission to improve product quality.
Able to assist people in finding creative solutions around constraints.
Strong analytic skills as proven by track record for analyzing complex problems
Strong technical report writing skills
Must be proficient in the use of Microsoft Office suite of applications.
Able to verify assembly documentation accuracy and to read engineering drawings
Understanding of product risks and experience identifying improvements to FMEA and risk management documentation

Nice To Haves

Knowledge of Good Manufacturing Practices & Quality Systems Regulations is a plus.
Familiarity with SAP and Tableau is a plus.
Familiarity with SQL and Snowflake is a plus.
Knowledge of basic statistical analysis methods is desirable.
Understanding of various advanced failure analysis tools/methodologies (ex: FTIR, SEM-EDS, fractography) is desirable.

Responsibilities

Perform failure analysis in conjunction with Service Operations technicians, FA Engineers and other Engineering teams on returned devices utilizing design documentation, system log data, software tools, and a variety of lab / bench equipment.
Perform robust analysis rooted in an understanding of our product hardware and software, and interface with clinical engineering to better understand use conditions in the clinical / operating room environment that might contribute to the failure mode.
Work with the Post Market Surveillance team in resolving questions around potentially reportable failures.
Assist in the processing, disposition and tracking of returned devices.
Give quality engineering, manufacturing and design teams guidance on failure modes.
Work with data analysis team on assessing failure trends and statistics.
Work with Engineering to identify opportunities for improvements in product quality, reliability, manufacturability, cost and functionality.
Work with Quality, Engineering, and Regulatory groups to develop new reports and failure codes as needed.
Work with Service Operations team to provide guidance on recording failure analysis results for improved consistency and accuracy.
Perform technical training on product to non-technical staff.
Create queries to perform RMA/complaint data analysis.