Intuitive Surgical Careers

Senior Quality Engineer

US-CA-Sunnyvale, California
Regulatory and Quality


Job Description

Job: Regulatory and Quality
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 181705

Description

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

 

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:
50% involvement in new product development, 25% failure investigation, 25% quality advocacy and project management.

1) 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 Quality
- Data Quality
- Process Quality
2) Product Development
o Handle projects of various product and subsystem types (System, 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 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 Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and reports
3) 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

Skill/Job Requirements:
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:

• Education: degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• At least two areas of deep technical expertise applicable to the manufacture of medical robotic systems. A minimum of 5 years’ experience in one of these disciplines and a few years in a second discipline. Example areas of expertise:
o Quality science and quality management
o Quality statistics
o Medical device software development, software quality best practices
o Controls, algorithm development
o Mechanical engineering, with experience relevant to robotic systems
o Electrical engineering, with experience relevant to robotic systems
o Design for reliability, manufacturability, serviceability
• Proven ability to work in teams and to project-manage cross-functionally
• Strong interpersonal and communication skills
• Ability to influence others:
o Passionate about our mission to improve product quality
o Able to use persuasive, logical arguments based on data
o Assist people in finding creative solutions around constraints
o Lead by example
• Strong analytic skills as proven by track record for analyzing and fixing complex problems
• A passion for doing the vital few things efficiently and well
• A strong desire to make work fun
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, production process control methodologies in a medical device environment
• Previous work experience with product design changes, process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment



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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