Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200052
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:
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 drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process. Intuitive seeks a strong technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most technically challenging quality problems. The ideal candidate possesses a broad base of experience and a high level of technical depth in at least two technical specialties applicable to medical robotics, and is equally at home in the test lab and providing technical leadership to our team as we develop standard practices of our organization. You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality. And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods.
Roles and Responsibilities:
This position has responsibility and authority for:
• Quality Advocacy and Project Management
o Develop and apply corporate level quality metrics.o Lead and project manage quality initiatives in one or more of these focus areas:Product QualityData QualityProcess Quality
• Product Development
o Handle projects of various product and subsystem types (Software, Mechanical Hardware, Camera, Disposable accessories like catheter, etc).o Development teams to develop measurable goals for quality.o Ensuring that the essential performance aspects are mitigated in the product quality plans.o Identify critical elements of designs. Recommend design processes and methods to meet quality goals: DFX, etc.o Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.o Plan and creation quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices.o Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.o Analyze and disposition of discrepant material.o Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.o Support development and execution of process validation and verification test plans, protocols, and reports
• Failure Analysis
o Provide quality expertise post market release to the quality engineering support team to analyze the returned product.o Perform deep technical failure analysis based on the physics of failure.o Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
Qualifications• Support other quality engineering initiatives as directed by the manager.
• 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 risk management, experience in generate FMEA and process FMEA.• Understands Design Controls, Change Controls, Product, and Engineering Processes.• Proficient with generate and execute Qualification and Validation protocol and Quality Assurance Procedures.• Experienced in leading product containment and rework activities.• 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).• Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able to create Multi-source report, trends, and interprets data with minimal oversight.• Capable of thinking independently and make decision based on limited information.• Capable of initiating improvement discussion and lead the team toward the goal.• 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).
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.