Quality Engineer 3
3 weeks ago
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 proven technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, drive projects to implement these initiatives, and serve as a professional 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. Position Details: The position is a Quality Engineer to be in Sunnyvale, California and will interface and support manufacturing operations.
Position Details:
The position is for a Quality Engineer in Sunnyvale, California and will interface and support new product development and manufacturing operations for Single Port business unit.
Roles & Responsibilities:
- Initial Roles and responsibilities for this position has responsibility will include the following: 50% in new product development, 20% involvement in supporting manufacturing operations, 10% failure investigation, 10% preforming complex inspection and 10% quality advocacy and project management.
- Develop and apply corporate level quality metrics.
- Drive and project manage quality initiatives in one or more of these focus areas: Product Quality, Process Quality, Production facility validation planning, execution, and documentation.
- Product Development-Handle projects of various product and subsystem types (Instruments and Accessories for SP System - new products, product improvements, etc.)
- 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.
- 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.
- Develop and implement methods and procedures for disposition of discrepant material.
- Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
- Failure Analysis- Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
- Perform deep technical failure analysis based on the physics of failure.
- 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.
Requirements:
- Minimum Education: bachelor's degree in electrical, mechanical or system engineering, math, or physics, advanced degree preferred.
- Minimum 4+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 2 years in medical device design or manufacturing environment
- Understands 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 trends)
- 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
Personality Requirements:
- Able to cope with changes and uncertainties; and handle associate risks comfortably.
- Able to ask meaningful questions and solve issues in a least burdensome approach.
- Motivated by results.
- 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 personal goals aligning with the team goal.
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