Primary Function of Position:
As Intuitive's 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 seek 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.
The position is a Senior Quality Engineer to be in Sunnyvale, California and will interface and support manufacturing operations for ION Endoluminal business unit.
Roles and Responsibilities:
Initial Roles and responsibilities for this position has responsibility will include the following:
50% involvement in supporting design and manufacturing projects, 15% failure investigation, 10% performing complex inspection and 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:
o Product Quality
o Data Quality
o Process Quality
· Production facility validation planning, execution, and documentation.
o MVP for building, product, and process located in Sunnyvale, CA.
· Product Development
o Handle projects of various product and subsystem types (System, Instruments, Vision, new products, product improvements, etc).
o Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at ISI Sunnyvale, ISI Mexicali, and OEM suppliers, utilizing clinical and engineering knowledge.
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 Develop and implement methods and procedures for disposition of discrepant material.
o Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
· 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.
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:
· Minimum Education: Bachelor's degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
· Minimum 8+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 4 years in medical device design or manufacturing environment.
· Has good understanding of Quality and compliance System.
· Understands of CFR 21 820/ ISO 13485 requirements for making process or design changes.
· Have good grasp of quality control and tools.
· Able to learn the product and process quickly and assesses defects' impact to product.
· Understands root cause investigation process and able to initiate routine problem solving investigations.
· Involved in Design and Process improvement projects in the past.
· Able to review Qualification and Validation protocols.
· Understands manufacturing metrics.
· Understands basic Excel data analysis operations (e.g. Pareto, charts and trend).
· Able to work in various project teams as the Quality SME.
· Able to communicate work tasks to various project team members.
· Capable of Compiling data in format appropriate for presentation.
· 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.
· Listens and respects others. Demonstrates constructive work relationship with others in the organization.
· Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets individual goals aligning with the team goal.
All your information will be kept confidential according to EEO guidelines.
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Shift : Day
Travel : NoneTravel Requirements:None Shift:Day