Intuitive Surgical Careers

Senior Continuous Improvement Quality Engineer

US-CA-Sunnyvale, California
Manufacturing & Operations


Job Description

Job: Manufacturing & Operations
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 183079

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.

The Post Market team at ISI works at the intersection of Regulatory and Quality. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues and, support the execution of robust resolutions. Functions within the Post Market team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Failure Analysis Engineering, and Continuous Improvement Quality Engineering. The Post Market Team advocates for safety and effectiveness improvements by assessing field product performance and QMS processes to identify, investigate, communicate, and execute on opportunities.

The Continuous Improvement Quality Engineering Team requires a Sr. Continuous Improvement Quality Engineer with strong, hands-on experience in problem solving, technical savvy with complex electro-mechanical devices, and passion for the best practices to analyze, monitor, and improve product and process.


Responsibilities:

Reporting to the Sr. Manager, Continuous Improvement Quality Engineering, the Sr. Continuous Improvement Engineer is responsible for creating and supporting a quality culture by driving compliance activities around the CAPA Program, partnering across the organization to manage continuous process/quality improvement programs that strongly align with ISI standards and customer needs while meeting all applicable Medical Device Regulations and Standards. S/he will partner with subject matter experts on various corrective and preventive (CAPA) activities in addition to supporting other improvement initiatives. S/he will evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality management system. The CIQE will work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure we are seeing ‘all the way around’ issues for complete resolution. S/he will participate in internal/external audits as necessary representing the CAPA Program.

Qualifications

Competency Requirements:

Competency is based on: education, training, skills and experience. In order to adequately perform the responsibilities of this position the individual should possess the following:


• Bachelor’s degree (Engineering or equivalent) combined with minimum 6 years of related experience in Quality, Engineering, Operations, or a continuous improvement environment.
• Strong interpersonal and communication skills:

o Passionate about making products and processes better
o Able to assist people in finding creative solutions around constraints.
o Able to deliver presentations to a broad audience

• Knowledge of Quality Systems Regulations (21 CFR 820) and ISO 13485 preferred.
• Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus.
• ASQ certification (CQE) is a plus.
• Experience gathering/processing internal and external requirements.
• Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results.
• Proven ability to drive creative problem solving related to product and process issues.
• The ability to collaborate effectively with product and/or process subject matter experts in a cross-functional team environment is required.
• Technical Aptitude is required to collect and analyze data for determining an improvement strategy
• Ability to navigate multiple projects with changing priorities. Ability to execute to project timelines. Project Management experience preferred.
• Ability to travel up to 10% of the time.

 

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.