At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique.
As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.
We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care.
As Intuitive’s da Vinci® Surgical System becomes adopted by an increasing population of hospitals, surgeons and patients around the world, 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 and design control problems, your fascination with complex electro-mechanical devices and software, and your passion for the best practices to design, monitor, and improve product. Intuitive seeks a strong technical contributor who can help guide the design control processes for product development and improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most challenging quality problems. The ideal candidate possesses a broad base of experience with quality standards, and a high level of technical depth in at least one technical specialty applicable to medical robotics, and is at home providing technical and process leadership to our team as we maintain and 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 while meeting regulators’ expectations for design history recordkeeping. And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, protocol development, and documentation practices.
Roles and Responsibilities:
This position has responsibility and authority for:
40% Design Control Process, 30% Training and Team Support, 30% Quality Mentorship.
- 1) Quality Advocacy and Design Control Process Management
- Maintain, develop, and apply corporate-level Operating Procedures for Design Control, including for creating and maintenance of Design History Files.
- Recognize opportunities to improve design control documentation processes via cross-functional process or management changes and propose efficient solutions that meet requirements for product types ranging from capital equipment, small devices, disposables, software, and services.
- Work with Project Management Office, Information Technologies, and other cross-functional partners to continually improve ease-of-compliance for fast-moving project teams.
- Perform Routine Checks of Design History files for completeness and accuracy.
- 2) Training and Team Development
- Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
- Provide training, teaching, or mentoring as needed for design for quality practices, protocol development, design of experiments, and the correct application of statistical techniques.
- 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
- Work with teams to correct incomplete or incomplete documentation
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must have:
- Education: degree in science, or in electrical, software or system engineering. Advanced degree preferred.
- At least one area of deep technical expertise applicable to the manufacture of medical robotic systems. A minimum of 7 years of 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 while providing innovative products rapidly to our customers
- Able to use persuasive, logical arguments based on data
- Assist people in finding creative solutions around constraints
- Lead by example
- 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.
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.
Shift : Shift 1 - Day
Travel : No