Intuitive Surgical Careers
Quality Engineer, China Integration
Primary Location: United States-California-Santa Clara County-Sunnyvale
Intuitive Surgical: What MattersJoining 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:
Intuitive Surgical (ISI) has established the preeminent position in surgical robotics with presence in more than 60 countries around the world. China represents a key market to Intuitive that has unprecedented growth opportunities driven largely by unmet patient and disease needs.
A Joint Venture (JV) between ISI and Fosun Pharma – a subsidiary of Fosun International, a leading Pharma and Medical Device Company in China – has been established to accelerate the opportunities within this key market. The intent of the JV is to research, develop and manufacture innovative, robotic-assisted catheter-based medical devices.
The Quality Engineering Department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The department plays a vital role in product and process quality, in new product development and production, and in the quality of all Intuitive Surgical product lines, including system platforms, endoscopic instrumentation, and reposable devices and supporting accessories.
This Joint Venture will be looking for Product Quality Engineer that will work with a multi-cultural team of dedicated individuals to ensure production transfer and delivery of a new platform with its associated instruments and accessories and will serve as an essential interface between Intuitive Surgical Inc and a Partner Factory.
Essential deliverables will include limited quality system development, design assurance, process controls, Master Validation Plan development, assistance with supply chain development from a quality perspective, line qualification, and others as outlined below.
The work of this full-time role is expected to last 18-24 months while the Joint Venture becomes fully operational. This role will require 30-50% travel to China.
Roles and Responsibilities:
This position has responsibility and authority for:
• Quality Advocacy and Project Management.• Development and application of corporate level quality metrics and reports.• Leadership and project management of quality initiatives in one or more of these focus areas:
o Product Qualityo Data Qualityo Process Qualityo Limited Quality Management System Development
• Adapting the requirements of ISI Quality Management System (QMS) to the partner. company’s QMS as applicable to risk management, product quality operations and design control.• Production facility validation planning, execution, and documentation.
o MVP for building, product, and process for a new facility.
• Product Development
o Handle projects of various product and subsystem types (System, Instruments, Accessories, Software, Hardware, Mechanical, Vision, new products, product improvements, etc).o Work with product development teams to develop measurable goals for quality. Participate in the risk management process ensuring that the essential performance aspects are correctly mitigated in the product quality plans.o Identify critical elements of designs based on design details and data-driven review of past designs. Recommend design processes and methods to meet quality goals: DFX, etc.o Work with the design teams to co-design robotic systems to enable self-diagnostic capabilities.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 direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices 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 Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and reports.o Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.o Releases process and document changes through engineering change orders and deviations using ISI change control processo Represents department cross-functionally in meetings that may include engineers, management, and external personnel
o Provide quality related functions training on activities associated with product acceptance and PQA associated QMS policies.o Training personal on the QMS procedures associated to risk management, product operations and design control• Failure Analysis
o Analyze failed or 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:
• Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.• 5+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 3 years in medical device design or manufacturing environment.• Has basic understanding of Quality and Compliance System.• Understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.• Able to support FMEA, and understands product risks.• 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.
• Impeccable integrity• Bilingual English-Mandarin a plus verbal and written skills• Able to work in both US and China with up to 50% travel• Able to cope with changes and uncertainties; and handle associated 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.