Intuitive Surgical Careers
Failure Analysis Engineer
Primary Location: United States-California-Santa Clara County-Sunnyvale
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Primary Function of Position:
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.
Roles and Responsibilities:
This position has responsibility and authority to:
• Perform Failure Analysis of RMA devices
o Perform technical failure analysis in conjunction with RMA FA technicians, FA engineers and clinical engineers.o Perform robust analysis rooted in an understanding of our product hardware and software, and interface heavily with clinical engineering to better understand use conditions in the clinical / operating room environment that might contribute to the failure mode.o Track failures and help identify concerns before they become trends• Work with the Post Market Surveillance team in resolving questions around potentially reportable failures
• Give quality engineering, manufacturing and design teams guidance on failure modes
• Work with data analysis team on assessing failure trends and statistics.
• Work with engineers and clinical engineers 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 RMA team to provide guidance on recording failure analysis results (consistency and accuracy)
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must have:
• Education: degree in mechanical engineering or other relevant engineering discipline.• A minimum of 3 years of experience in medical device engineering or failure analysis.• Proven ability to work in teams and to work cross-functionally.
• Strong interpersonal and communication skills:
o Passionate about our mission to improve product quality.
o Able to assist people in finding creative solutions around constraints.
• Strong analytic skills as proven by track record for analyzing complex problems
• Ability to verify assembly documentation accuracy and to read engineering drawings, etc. is desirable.
• Ability to examine a problem at a broad systems level to identify interrelationships and evaluate from multiple angles, and then to drill down into the details to understand the impacts of specific areas.
• Knowledge of Good Manufacturing Practices & Quality Systems Regulations is a plus.
• Must be proficient in the use of Microsoft Office suite of applications.
• Familiarity with SAP and Tableau a plus.