Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 180902
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.
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 emerging 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.
Primary Function of Position:
50% involvement in new/marketed product development, 25% failure investigation, 25% quality advocacy and project management.
- Quality Advocacy and Project Management.
- Develop and apply corporate level quality metrics.
- Lead and project manage quality initiatives in one or more of these focus areas:
- Product Quality
- Data Quality
- Process Quality
- Product Development
- Failure Analysis
- Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
- 5+ years of working experience in Quality Engineering, minimum 3 years in medical device design or manufacturing environment.
- Able to navigate quality and compliance system with minimal oversight on individual projects.
- Demonstrated Understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.
- Understands product risks, able to generate FMEA.
- Have good grasp of quality control and tools.
- Able to drive larger scale quality improvement initiatives.
- Understands and can quantify defect.
- Involved in Design and process improvement projects in the past.
- Understands Design Controls, Change Controls, Product, and Engineering Processes.
- Able to generate and execute Qualification and Validation protocol and Quality Assurance Procedures.
- Solves complex problem without any oversight and begins training others.
- Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why’s, control charts, fishbone diagram).
- Able to create Multi-source report, trends, and interprets data with minimal oversight.
- Uses data to quantitatively communicate problem or issue.
- Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions).
- Able to plan complex project with cross functional team, coordinates and prioritize tasks with minimal oversight.
- Able to advise Peers.
- Leads small project team in the past.
- Makes decision with supportive evidence.
- Operates with minimal oversight for problems or assignments of reasonable difficulty.
- Makes decision inefficient manner. (e.g. Gets consensus, works through challenges. Understands the why and priority behind projects and tasks to facilitate decision making.)
- Can present information in various forms and forums, collaborates with peers across functions. Experience in presenting to cross functional mgmt. communications. (e.g. report writing, presentations, QRB presenter).
- Able to cope with changes and uncertainties; and handle associate risks comfortably.
- Ask questions and don’t stop at the first answer. Analyze deeply to ensure the solution is the most effective solution.
- Brings unpleasant facts to discussion, does not hold back information.
- Driven by results. Fully supports team decision, even if he/she disagrees with the decision.
- Enjoys working hard and learning when opportunities arise.
- Gives credit to others for success, and does not blame others for his/her mistakes. Doesn’t misrepresent him/herself for personal gain or protection.
- Listens and respects others. Demonstrates constructive work relationship with others in the organization.
- Offers suggestions for doing things differently, brings measurable evidence to support each decision. Able to breakdown complex issues into simplified task.
- Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets individual goals aligning with the team goal.
- Understands that the real success is the success of the whole team.
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.
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