Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 193910
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.
Primary Function of Position:
The Post Market Investigation Engineer uses a strong firsthand knowledge of da Vinci® products, Intuitive processes, and regulations to work with technical and regulatory experts (internal and external), complaints analysts, the commercial team, clinical engineers, and customers to assess existing and potential failures within the Intuitive Surgical product lines. These products include instruments, accessories, robotic systems, vision systems, and other related products & features. The primary focus of this individual is to assess:
1. How and why products in the market may have gaps between their expected and actual performance in addition to assisting the product engineering and other support teams to determine the best way to close those gaps.
2. How and why Intuitive Post Market Investigation processes may have gaps between expected and actual procedures in addition to assisting the risk management, Regulatory Post Market Surveillance (RPMS), Post Market Investigation (PMI), and other teams to determine and execute on the best way to close those gaps
The ideal candidate possesses a solid technical background complimented by regulatory/compliance experience along with a natural curiosity to ask the right questions. Further, they should be comfortable communicating nuanced technical and regulatory information across multiple levels of the organization.
Roles and Responsibilities:
This position has responsibility and authority to:
• Engage broadly with the post market team to assist with the investigation and analysis of emergent issues as needed.
o Work alongside data analysis team to constantly improve how we analyze failure trends
o Analyze complaint record data to identify trends and patterns that may represent opportunities to reduce or eliminate specific customer issues. Summarize and prioritize these findings in the form of recommended actions and projects showing anticipated benefits to customers and ISI
o Lead deep cross-functional root cause investigations on potential product compliance issues and communicate outcomes across different functions and levels within the organization
• Manage customer escalations from field signals (Including sales, marketing, and customer letters) with support from cross function teams to understand concerns and provide guidance on resolution
• With the risk management team, drive updates to risk management documentation and risk management methodology to improve Post Market systems and processes
• Assist the team in planning, preparing and reviewing information to be presented at quality data review (QDR) weekly/monthly meetings. Provide oversight of QDR activities owned by Failure Analysis Engineering (FAE) and other departments (i.e. Product Quality)
• Support audit activities associated with Post Market Investigation processes
Competency Requirements - In order to adequately perform the responsibilities of this position the individual must:
• Education: degree in mechanical engineering or other relevant engineering discipline. Master’s degree preferred.
• A minimum of 8 - 10 years of experience in a medical device engineering function with relevant exposure to clinical use of products and customer interaction
• Proven ability to lead teams and work cross-functionally.
• Strong interpersonal and communication skills:
o Passionate about our mission to constantly make our products better
o Able to assist people in finding creative solutions around constraints
• Strong analytic skills as proven by track record for analyzing complex problems
• Proven ability to navigate large datasets to extract essential themes and trends
• Knowledge of Good Manufacturing Practices & Quality Systems Regulations, including a focus in risk management methodology.
• Must be proficient in the use of Microsoft Office suite of applications.
• Familiarity with Trackwise and SAP a 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.