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 primary responsibility for:
• Lead product nonconformance investigation, such as robotic assemblies not performing to specification and component out of tolerance. For each nonconformance investigation this quality engineer will also lead the assessment of usage risk. This Quality Engineer will also support the determination of root cause and countermeasures to prevent recurrence of the nonconformance.
• Analyze internal and external product data to identify improvement opportunities, initiate projects that will improve the quality of the Intuitive products.
• Monitor quality metrics. Present quality metrics to management team and operation team, pinpoint the areas that need improvement.
Quality Systems & Risk Management
• Navigates quality system independent of oversight. Develops project plans including the proposed quality system risks & benefits. Makes updates to improve quality systems and mentor others. Analyzes RMAs, QNs and make the necessary updates to risk documents.
• Compliance- Able to articulate the latest and complex regulation to project team. Able to understand the impact of regulations to our procedures and make the corresponding SOP/DOP updates. Able to contribute in external audits, perform internal audits.
• 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 compliant solutions which meet constraints. Lead by example
• A passion for doing the vital few things efficiently and well
• A strong desire to make work fun
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:
• Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• 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.
• 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).