Intuitive Surgical Careers

Senior Manager Failure Analysis Engineering

Sunnyvale, California
Quality


Job Description

Job: Quality
Primary Location: United States-California-Santa Clara County-Sunnyvale
Schedule: Full-time

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.



Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Intuitive Surgical

Surgical robotics was little more than a medical curiosity until 1999, the year Intuitive Surgical introduced the da Vinci® Surgical System. Today, Intuitive Surgical is the global leader in the rapidly growing field of robotic-assisted minimally invasive surgery. Since its inception, the company has consistently provided surgeons and hospitals with the tools needed to improve clinical outcomes and to help patients return to active and productive lives. With its corporate headquarters located in Sunnyvale, California, Intuitive Surgical serves customers throughout the United States and internationally, providing technology and procedural innovation across cardiac, urology, gynecologic, pediatric and general surgical disciplines.

Post Market Team:

The Post Market team at ISI works at the intersection of Regulatory, Quality and Engineering. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues and they support the execution of robust resolution. The functions within the team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Failure Analysis Engineering, and Continuous Improvement Engineering.

Post Market Team Mission Statement:

The Post Market Team advocates for patients and surgeons by thoroughly understanding, investigating, communicating and improving the performance of product/process. This is achieved by:

• Executing with urgency while delivering the highest quality of data, investigations and analysis
• Ensuring compliance to all global regulations
• Driving cross-functional collaboration

Failure Analysis Engineering:

Intuitive Surgical continues to be a fast-growing company that requires leaders with strong, hands-on experience in analyzing engineering problems, is technically savvy with complex electro-mechanical devices, and has a passion for the best practices execute robust failure analysis across our product lines. The Failure Analysis Engineering function is a relatively new group at Intuitive Surgical within the Post Market team. The failure analysis team is essential in deeply understanding the performance of our products in the field and communicating broadly across the organization.

The Sr. Manager of Failure Analysis Engineering uses their deep working knowledge of the da Vinci® Systems, instruments, accessories to work with engineers, clinical engineers and technicians to assess existing and potential issues within the Intuitive product lines. Their primary focus is to assess how and why products in the market may have gaps between their expected and actual performance.

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 rigorously assess reliability, quality, and safety of our products. This knowledge and data is critical to the organization in order to passionately pursue improved device performance and best inform our next generation products. This is where 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 can make a direct impact. Intuitive seeks a strong technical contributor and leader who can work with failure analysis engineers and technicians to rigorously assess issues identified in the market, solve challenging problems and identify key opportunities for product improvement. The ideal candidate possesses a strong ability to ask the right questions, to build a top-notch team and who can communicate key learning across multiple parts of the organization. They must be passionate about the work they do and be an advocate for the patient always.

Roles and Responsibilities:

This position has responsibility and authority for:

  • Building and leading a team to execute robust Advanced Failure Analysis of returned system components, instruments, accessories and other ISI products.
o Perform technical failure analysis in collaboration with RMA FA technicians, engineers and clinical engineers
  • 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
  • Track failures and help identify concerns before they become trends
  • Assist Post Market Surveillance team in resolving reportable events and inform content to be used in customer communication letters
  • Establish FA processes to create an efficient method to support the needs of the business but still ensure deep analysis of product issues
  • Give quality engineering, manufacturing and design teams guidance on failure modes and statistics
  • Collaborate with engineers and clinical engineers to identify opportunities for improvements in product quality, reliability, manufacturability, cost and functionality
  • Collaborate with Quality, Engineering, and Regulatory groups to develop new reports and failure codes as needed
  • Collaborate with RMA team to provide ongoing guidance on recording failure analysis results (consistency and accuracy)
  • Proven ability to develop and coach engineers at various experience levels
  • The ability to collaborate effectively with senior level management in a cross-functional team environment
  • Team Player and Leader - demonstrated ability to lead, contribute to teams, and understand team dynamics 
Qualifications

Skill/Job Requirements:

Competency Requirements: In order to adequately perform the responsibilities of this position the individual must: 

• Education: degree in engineering, physics or similar
• A minimum of 5 years of experience in medical device engineering, failure analysis or similar.
• A minimum of 5 years in a technical leadership position or equivalent experience
• Proven ability as a strong leader and solid cross-functional communicator
• Strong interpersonal and communication skills:
• Able to assist people in finding creative solutions around constraints.
• Passionate about our mission to continuously improve our products.
• Strong analytic skills as proven by track record for analyzing complex problems
• Ability to verify assembly documentation accuracy and to read engineering drawings, etc.
• 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 Tableau and SQL a strong plus.

We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

#LI-ZY1