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 an effective technical contributor who can help define practical, useful quality metrics and specifications, identify key opportunities for product improvement, launch quality initiatives, drive projects to implement these initiatives, and serve as an experienced 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 seek 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.

Position Details:

The position is a Quality Engineer to be in Sunnyvale, California and will interface and support manufacturing operations for Single Port business unit.

Roles and Responsibilities:

• Involvement in supporting product development, manufacturing, and sustaining activities for single-use and multi-use instruments and/or accessories.
• New Product Introduction and Continuous Improvement
  • Partner with manufacturing/supplier teams to effectively transfer products and processes (Design Transfer) into the production environment and support these products within the production environment.
  • Production facility validation planning, execution, and documentation; MVP/MVR for building, product, and process located in Sunnyvale, CA; assist in production transfer activities as appropriate.
  • Provide support to product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
  • Provide quality engineering support on product related issues arising from manufacturing using appropriate quality notifications, accountable for containment, risk and product impact assessments, disposition, and any escalation decisions.
  • Represent Product Quality for the applicable product line in periodic quality data review meetings, responsibilities include data collection, analysis, and identification of corrections/corrective actions in collaboration with cross functional stakeholders.
  • Responsible for the analysis of product failures and/or non-conformances and drive product and/or process improvement opportunities; drive failure investigations, review engineering assessments, and support projects that addresses said failures.
  • Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices, utilizing clinical and engineering knowledge.
• Product Development
  • Contribute to the product development efforts, primarily responsible for overseeing the execution and review of design controls, process controls, and risk management.
  • Creation of Risk Management Plans and Reports and contribute to the creation and review of Top-down and bottom-up risk analysis by collaborating cross-functional.
  • Understand and support linkage of post market and production and process controls data to the elements of Risk Management and Design Controls
  • Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.
  • Assist in supplier selection, qualification, certification, and performance improvement.
  • Partner with engineering to define design inputs, design outputs, and traceability matrices.
    • Responsible for conducting change assessments for design and process changes for applicable product lines
    • Support internal and external audits, including preparation and direct interaction with auditors.

Qualifications

Skill/Experience/Education/Training:

• Minimum Education: Bachelor’s degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• Minimum 5+ years of working experience in Quality Engineering, or in manufacturing environment; minimum 4 years in medical device design or manufacturing environment.
• Understands Quality and compliance System.
• Understands of CFR 21 820/ ISO 13485 requirements for making process or design changes.
• Have good grasp of quality control and tools.
• Able to learn the product and process quickly and assesses defects’ impact to product.
• Understands root cause investigation process and able to initiate routine problem-solving investigations.
• Involved in Design and process improvement projects in the past.
• Able to review Qualification and Validation protocols.
• Understands manufacturing metrics.
• Understands basic Excel data analysis operations (e.g., Pareto, charts, and trend).
• Working Knowledge on Tableau and Snowflake is a plus.
• Able to work in various project teams as the Quality SME.
• Able to communicate work tasks to various project team members.
• Capable of Compiling data in format appropriate for presentation.

Personality Requirements

• 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.
• Passionate by results. Fully supports team decision, even if he/she disagrees with the conclusion.
• Listens and respects others. Demonstrates constructive work relationship with others in the organization.
• Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets personal goals aligning with the team goal.