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 one or 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.
Roles and Responsibilities:
This position has responsibility and authority for:
50% involvement in new/marketed 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:
- Product Quality
- 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.
- Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
- Have a solid understanding of lean principles and identify wastes to maximize customer value.
- 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.
- Risk Management
- Participate in Risk Analyses for new and existing products, including review of both hardware and software.
- Work with Design Engineering to maintain tracing of risk to requirement to test.
- Participate in review of technical and quality information for regulatory submissions.
- Have a strong understanding of risk assessment and root cause techniques.
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:
- Minimum Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
- Minimum 5+ years of working experience in Quality Engineering or related field, minimum 3 years in medical device design or manufacturing environment.
- Able to navigate quality and compliance system with minimal oversight on individual projects.
- Demonstrated Understanding of CFR 21 820/ ISO 13485 requirements for making process or design changes.
- Understands product risks, able to generate FMEA.
- Have good grasp of quality control and tools.
- Able to drive larger scale quality improvement initiatives.
- Understands and can quantify defect.
- Involved in Design and process improvement projects in the past.
- Understands Design Controls, Change Controls, Product, and Engineering Processes.
- Able to generate and execute Qualification and Validation protocol and Quality Assurance Procedures.
- Solves complex problem without any oversight and begins training others.
- Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
- Able to create Multi-source report, trends, and interprets data with minimal oversight.
- Uses data to quantitatively communicate problem or issue.
- Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions).
- Able to plan complex project with cross functional team, coordinates and prioritize tasks with minimal oversight.
- Able to advise Peers.
- Leads small project team in the past.
- Makes decision with supportive evidence.
- Operates with minimal oversight for problems or assignments of reasonable difficulty.
- Makes decision inefficient manner. (e.g. Gets consensus, works through challenges. Understands the why and priority behind projects and tasks to facilitate decision making.)
- Can present information in various forms and forums, collaborates with peers across functions. Experience in presenting to cross functional mgmt. communications. (e.g. report writing, presentations, QRB presenter).
- Has strong integrity.
- Able to effectively present and communicate to cross-functional teams.
- Is a problem solver and is able to systematically analyze issue on hand.
- Eager to learn and grow.
- 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 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.