Amick Brown is seeking an experienced Failure Analysis Engineer
for our direct client.
: Santa Clara, CA
: 9 months
- 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 Clients 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
- Perform Failure Analysis of RMA devices
- Perform technical failure analysis in conjunction with RMA FA technicians, FA 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
- Work with the Post Market Surveillance team in resolving questions around potentially reportable failures
- Assist in the processing, disposition and tracking 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 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)
- Education: degree in mechanical engineering or other relevant engineering discipline.
- A minimum of 2 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:
- 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
- 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.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs