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 the Position

Intuitive (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 medical devices.

The Quality Engineering team is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The team plays a vital role in product and process quality, in new product development and production, and in the quality of all product lines, including system platforms, endoscopic instrumentation, and reposable devices and supporting accessories.

This Joint Venture will be looking for a Senior Quality Engineer that will work with a multi-cultural team of dedicated individuals to define practical, useful quality metrics, 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 problem, and will serve as an essential interface between Intuitive and the partner factory. The ideal candidate possesses a broad base of experience and a high level of technical depth. 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.

The position is a Senior Quality Engineer to be in Sunnyvale, California and will interface and support manufacturing operations for Joint Venture. This is a full-time role will require 10-20% travel to China.

Essential Job Duties

This position has responsibility for:

• Quality Advocacy and Project Management.
• Development and application of corporate level quality metrics and reports.
• Lead and project manage quality initiatives in one or more of these focus areas:
  • Product Quality
  • Data Quality
  • Process Quality
  • Quality Management System Development

• Production validation planning, execution, and documentation.
  • MVP for building, product, and process for a new facility.
• Product Support
  • Handle projects of various product and subsystem types (System, Instruments, Accessories, Software, Hardware, Mechanical, Vision, new products, product improvements, etc).
  • Support product transfer projects, transfer and implement quality assurance procedures, sampling plans, methods, equipment and processes
  • Provide support to commercial product distribution and support to manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
  • Responds to quality escalations and provides technical support for troubl