Staff 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 Ion ® 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 seek the most efficient way to build 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.

Position Details:

The position is a Staff Quality Engineer located in Sunnyvale, California and will support product field issues for ION endoluminal business unit.

Roles and Responsibilities:

Initial Roles and responsibilities for this position will include the following:

40% involvement in supporting escalations for product in the field, 20% failure investigation, 20% performing product escalation evaluations and 20% quality advocacy and project management.

• Failure Analysis
  • Assist in complaint analysis and manufacturing failures to understand failure modes to assist with keeping risk documentations up to date and escalate any issues as needed.
  • Perform deep technical failure analysis based on the physics of failure.
  • 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.
• Quality Advocacy and Project Management.
• Escalation management
  • Able to work with extended team to understand design and process details of the failure mode and patient impact.
  • Work with product teams to understand the root cause, perform bracketing and containment accordingly.
  • Maintain documentation to ensure failure mode is appropriately captured and resolved.
  • Ability to present the issue at hand to management and board members.
  • Be able to multi-task and manage escalations to ensure investigations are completed in a timely manner.
• Lead and project manage quality initiatives in one or more of these focus areas:
  • Product Quality
  • Data Quality
  • Process Quality
  • Risk Management

• Product and Process Development
  • 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.
  • Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the Intuitive products.
  • 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 Intuitive Sunnyvale, Intuitive Mexicali, and OEM suppliers, utilizing clinical and engineering knowledge.
  • Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
  • Identify any quality systems process improvement areas and implement process improvements.

• Develop and apply corporate level quality metrics.

Qualifications

Skill/Job Requirements:

Competency Requirements: To adequately perform the responsibilities of this position the individual must possess:

• 
  Minimum Education: Bachelor’s degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• Minimum 12+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 6 years in medical device design or medical device manufacturing environment.
• Understands Quality and compliance System.
• Understands CFR 21 820/ ISO 13485 requirements for making process or design changes.
• Have a good grasp of quality control and tools.
• Able to learn the product and process quickly and assess 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 review qualifications and validation protocols.
• 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.

Personality Requirements

• Able to cope with changes and uncertainties, and handle associate 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 they disagree with the decision.
• Listen and respects others. Demonstrates constructive work relationship with others in the organization.
• Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets individual goals aligning with the team goal.

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.

Base Salary Range Region 1:$157,400 - $226,600
Base Salary Range Region 2: $133,800 - $192,600
Shift: Day
Travel: None
Workplace Type: Onsite - This job is fully onsite.