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Staff Quality Engineer Risk Management

Job Description

Job: Manufacturing & Operations
Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 194084

Description

Primary Function of Position:

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.

As Intuitive’s da Vinci® Surgical System continues to become the standard of care across many surgical specialties, we are continually building our 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 fast paced company by bringing your hands-on experience in solving tough quality process 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 and team leader 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 multiple specialties applicable to medical robotics and other therapies. You are equally at home in the test lab and providing technical leadership to our team as we develop standard practices for 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, risk management, data analysis, protocol development, and design for quality and reliability methods.

Roles and Responsibilities:


This position has responsibility and authority for:

 1) Quality Advocacy and Project Management
o Develop and apply corporate level, data driven quality processes and metrics.
o Recognize opportunities to improve product quality via cross-functional process or management changes and propose solutions:
o Educate others in implementation of new processes and ensure adherence.
o Identify issues that prevent engagement with quality processes and make suggestions to functional managers to alleviate them. Ensure actions of cross functional team members reflect values of organization.
o Lobby for support of quality initiatives. Reach out and influence through rational discussion.
o Support for process improvement initiatives at the highest level, including CAPA consultation, Standards overviews, and forward-looking initiatives.
o Generate and make known resources for teams to learn more about, and be more adept in, quality processes at the corporate level:
 Risk Management
 Design Control
 Quality Initiatives
o Develop and deliver special quality training for targeted applications in Design Control and Risk Management
 Including both general classes and special team-focused classes
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 Provide guidance and Quality overviews to projects of various product and subsystem types (Instrument, System, Software, Hardware, Mechanical, Vision, new products, product improvements, etc).
o Work with product development teams to develop improved understanding of quality processes and outputs.
o Work with product development teams for proper implementation of Risk Management processes.
o Work with product development teams for proper implementation of Design Control processes.
o Raise new ideas; generate technical/product and process ideas for the company at a higher level.
o Perform 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.
o Act as a consultant to other engineers and management. Consistently providing training, teaching, or mentoring for ”design for quality” practices, protocol development, requirement writing, design of experiments, and the correct application of statistical techniques. Mentor “up, down and across” to especially related to risk management and design control.
 3) Special Projects
o Involvement in new standards (e.g., committees), new technologies, new processes.
o Manage by influence and example in other organizations not in direct chain of command.
o Lead by example

Qualifications

Skill/Job Requirements:

Competency Requirements: In order to adequately perform the responsibilities of this position the individual must have:

 Education: degree in engineering, math, or physics. Advanced degree preferred.
 Minimum of two areas of deep technical expertise applicable to the design and manufacture of complex medical devices. A minimum of 12 years’ experience in at least one of the following disciplines (with additional experience desired):
o Materials science, materials manufacturing processes, and failure analysis
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. Makes decisions across functions in known circumstances, effectively communicates strategies.
 Ability to make difficult priority decisions in dynamic circumstances.
 Strong interpersonal and written/verbal communication skills at all forums and levels of the organization
 Passionate about our mission to improve product quality
 Able to use persuasive, logical arguments based on data
 Influence to build bridges across teams to improve processes, communicate effectively and remove roadblocks to success
 Strong analytic skills as proven by track record for analyzing and fixing complex problems
 Continuously learning; explores new disciplines to self develop and help develop others
 A passion for doing the vital few things efficiently and well. Exceeds in consistency of performance and goes consistently beyond the norm.
 A strong desire to make work fun.

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.