Senior Quality Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

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 to support product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. This person will provide expertise and guidance to the team on Design Controls, Risk Management, Software Development Life Cycle, and Design for Reliability and Manufacturing. In addition, this position will play an effective role to ensure that the developed products meet quality standards consistent with Intuitive’ s quality processes, while meeting all external design control and regulatory requirements.

The ideal candidate possesses a broad base of experience and a high level of technical depth and technical leadership 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, design for quality, manufacturability, and reliability methods.

Position Details:

The position is a Senior Quality Engineer to be in Sunnyvale, California and will interface and support Single Port business unit.

Roles and Responsibilities:

• Contribute to the product development efforts on software and hardware projects, primarily responsible for overseeing the execution and review of design controls, process controls, risk management, and SDLC deliverables.
• Working knowledge of Design Controls, Risk Management, and Software Development Lifecycle Process; review and provide quality and compliance input to project teams for project decisions and associated deliverables (i.e. Design Inputs, Design Outputs, Design Reviews, Design V&V, Usability Testing, SW Validation, Design Transfer, Process Validation and Labeling).
• Support the development of product design history file and ensure compliance to internal processes and external standards and regulations.
• Partner with engineering to define design inputs, design outputs, and traceability matrices.
• Creation of Risk Management Plans and Reports and contribute to the creation and review of Top-down and bottom-up risk analysis by collaborating cross-functional.
• Understand and support linkage of post market and production and process controls data to the elements of Risk Management and Design Controls
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Provide quality leadership for new products and sustaining