Quality Engineer 3

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.

Roles & Responsibilities:

• Includes Design Control projects, production line support and failure investigation and providing guidance on Quality tools 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 Data Quality Process Quality
• Product Development
• Handle projects of various product and subsystem types (electromechanical, Mechanical Hardware, instruments, Disposable accessories like seals, drapes etc).
• Ensure that the essential performance aspects are inspected for as part of repair test process.
• Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
• 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.
• Support analysis and disposition of discrepant material.
• Support manufacturing/repair process changes: including, review and approval of change orders (ECO’s), reviewing tooling qualifications, and proactively ensuring repair processes stay aligned with any new changes introduced in new product manufacturing
• Development of Master Validation Plans for new facilities and products which include the identification of components and processes that require specific attention to assure the quality of the over-all products and the methods for applying that attention including the generation and/or oversight of the following:
• Applicable DOPs and SOPs
• Design Risk: FMEA, design V&V
• Process Risk: Process FMEA, Supplier Process FMEA, in-house Process V&V, supplier process V&V, EFT Qualifications, Line qualifications
• Generation of Quality Assurance processes for forward production including drawing reviews, incoming inspection plans, Quality Assurance Plans (QAPs), and Final Quality Inspection (FQI) procedures.
• Support development and execution of process validation protocols, and reports  
• Operations/Production Support and Failure Investigation
• Monitors manufacturing procedures, processes and records for compliance with established requirements.
• Reviews and trends product and process quality issues using data analysis.
• Evaluates deviations, non-conformances and supports resolution of quality issues.
• Responds to quality escalations and provides technical support for troubleshooting, repair, testing and supports root cause investigation along with design/manufacturing engineering.
• Performs risk analysis, product impact assessment and determines disposition for non-conformances.
• Escalates to management all quality issues that could impact patient safety or surgical efficacy.
• Ensures and supports on-time completion of department projects, communicates constriants to direct management when successful completion is at risk.
• Review and/or release process and document changes through engineering change orders and deviations using ISI change control process.
• 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:

• Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• 5+ years of working experience in Quality Engineering, 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 risk management, experience in generate FMEA and process FMEA.
• Understands Controlled Environment Room controls including periodic Bioburden and Endotoxin testing.
• Demonstrated understanding of single use disposable requirements (ex – sterilization requirements).
• Understands Design Controls, Change Controls, Product, and Engineering Processes.
• Proficient with generate and execute Qualification and Validation protocol and Quality Assurance Procedures.
• Experienced in leading product containment and rework activities.
• 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).
• Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able to create Multi-source report, trends, and interprets data with minimal oversight.
• Capable of thinking independently and make decision based on limited information.
• Capable of initiating improvement discussion and lead the team toward the goal.
• 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).