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 troubleshooting, repair and testing
  • Escalates to direct management all quality issues that could impact patient safety or surgical efficacy
  • 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.
  • Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk
  • Supports internal and external audits
• Failure Analysis
  • Perform technical failure analysis based on the physics of failure.
  • Perform risk analysis and determine quality disposition for variance requests and non-conformances
• QMS
  • Support gap analysis between Chinese regulations and ISI processes.
  • Establish new processes or modify existing processes to ensure regulatory compliance

Qualifications

Required Skills and Experience

• Minimum Education: Bachelor’s degree in electrical, mechanical, biomedical, or system engineering, math, or physics. Advanced degree preferred.
• Minimum 8 years of working experience in Quality Engineering, or in manufacturing environment, minimum 4 years in medical device design or manufacturing environment.
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Have good grasp of quality control and tools.
• Able to learn the complex 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 drive larger scale quality improvement initiatives.
• Solves complex problem without any oversight and begins training others.
• Able to plan complex project with cross functional team, coordinates and prioritize tasks with minimal oversight.
• Understands Design Controls, Change Controls, Product, and Engineering Processes.
• Experience in writing and reviewing Qualification and validation reports
• Understands manufacturing metrics.
• Understands basic Excel data analysis operations (e.g. Pareto, charts and trend).
• 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.
• Familiar with Chinese NMPA Decree 739, Order 53, and related standards and guidelines is a plus.
• Understanding Chinese Product Technical Requirements is a plus

Personality Requirements

• Impeccable integrity
• Able to work in both US and China with up to 20% travel
• Able to cope with changes and uncertainties; and handle associated risks comfortably.
• Ask questions and don’t stop at the first answer. Analyze deeply to ensure the solution is the most effective solution.
• Brings unpleasant facts to discussion, does not hold back information.
• Driven by results. Fully supports team decision, even if he/she disagrees with the decision.
• Enjoys working hard and learning when opportunities arise.
• Gives credit to others for success and does not blame others for his/her mistakes. Doesn’t misrepresent him/herself for personal gain or protection.
• Listens and respects others. Demonstrates constructive work relationship with others in the organization.
• Offers suggestions for doing things differently, brings measurable evidence to support each decision. Able to breakdown complex issues into simplified task.
• Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets individual goals aligning with the team goal.
• Understands that the real success is the success of the whole team.
• Bilingual English-Mandarin verbal and written skills are plus

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.