Failure Analysis Engineer 3

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 onimproving 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 Intuitives 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 an effective contributor who can help perform failure analysis identify key opportunities for product improvement and help solve challenging problems.

The ideal candidate possesses a 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 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.
• Excellent 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.
• Effective interpersonal and communication skills.
• Passionate about our mission to improve product quality.
• Able to assist people in finding creative solutions around constraints.
• Proven analytic skills as proven by track record for analyzing complex problems
• Good 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.

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

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.

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

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.

Remote Work :

No

Employment Type :

Full-time