Failure Analysis Engineer

Failure Analysis Engineer

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.

Essential Job Duties

• 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 the 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.

Qualifications

Required Skills and Experience

• 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

Required Education and Training

• Minimum Education: BS degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or other relevant engineering discipline.

Preferred Skills and Experience

• 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.

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 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.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

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.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.

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 compensation ranges are listed.