Quality Engineer 3

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 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 seeking 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.

• room environment.

Roles & Responsibilities:

• This position has responsibility and authority for: 50% involvement in new product development, 25% failure investigation, 25% quality advocacy and project management.
• Quality Advocacy and Project Management- Develop and apply corporate level quality metrics.
• Lead and project manage quality initiatives in one or more of these focus areas:-

1. Product Quality
2. Data Quality
3. Process Quality

Product Development- Handle projects of various product and subsystem types (System, Software, Hardware, Mechanical, Vision, new products, product improvements, etc).

• Work with product development teams to develop measurable goals for quality. Participate in the risk management process ensuring that the essential performance aspects are correctly mitigated in the product quality plans
• 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.
• Work with the design teams to co-design robotic systems to enable self- diagnostic capabilities.
• Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI 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 ISI Sunnyvale, ISI Mexicali, and OEM suppliers, utilizing clinical and engineering knowledge
• 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
• Develop and implement methods and procedures for disposition of discrepant material
• Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and reports

Failure Analysis- Provide quality expertise post market release to the quality engineering support team to analyze the returned product.

• 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.

Qualifications

Skills, Experience, Education, & Training:

• Minimum Education: Minimum degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• At least two areas of deep technical expertise applicable to the manufacture of medical robotic systems. A minimum of 5 years’ experience in one of these disciplines and a few years in a second discipline. Example areas of expertise:- Quality science and quality management
• Quality statistics
• Medical device software development, software quality best practices
• Controls, algorithm development
• Mechanical engineering, with experience relevant to robotic systems
• Electrical engineering, with experience relevant to robotic systems
• Design for reliability, manufacturability, serviceability
• Proven ability to work in teams and to project-manage cross-functionally
• Strong interpersonal and communication skills
• Ability to influence others:
• Passionate about our mission to improve product quality
• Able to use persuasive, logical arguments based on data
• Assist people in finding creative solutions around constraints
• Lead by example
• Strong analytic skills as proven by track record for analyzing and fixing complex problems
• A passion for doing the vital few things efficiently and well
• A strong desire to make work fun
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, production process control methodologies in a medical device environment
• Previous work experience with product design changes, process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment 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.

Additional Information

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.