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.

The position is a Quality Engineer-3 based out of Peachtree corners, GA and will support manufacturing and remanufacturing of systems for the Davinci Multiport (MP) business unit.

Essential Job Duties:

• Initial roles and responsibilities for this position will include the following:
• 60% involvement in supporting sustaining manufacturing operations, 25% design controls and 15% quality advocacy (quality improvements).
• Manufacturing support:
  • Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
  • Ensure manufacturing activities follow ISI procedures and regulations.
  • Support development and execution of process validation and verification test plans, protocols, and reports.
• • Maintain site level process FMEA and risk management files and update as required.
  • Support production ramp and work cross functionally on issue and support continuous improvement projects.
  • Support investigation and disposition of non-conformances, both internal and supplier related.
• Product development:
  • Support various product and subsystem type design changes (not a full design quality support)
  • Participate in risk management process ensuring that the essential performance aspects are correctly mitigated in the product quality plans.
  • Ensure design changes are established and implemented according to ISI standards and applicable regulations.
  • Recommend design processes and methods to meet quality goals (DFX, etc.).
• Quality Advocacy:
  • Develop and apply corporate-level quality metrics.
  • Ensure the quality system requirements are effectively established and maintained.
  • Lead and manage quality initiatives in one or more areas of product and processes quality.
  • Evaluates deviations and non-conformances and supports resolution of quality issues
  • Supports process validation and verification.
• Perform risk analysis and determines quality disposition for variance requests and non-conformances
• Represents the department cross-functionally in meetings that may include senior and external personnel
• Releases process and document changes through engineering change orders and deviations using ISI change control process
• Escalates to direct management all quality issues that could impact patient safety or surgical efficacy
• Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk.
• Performs other duties as assigned by the management.

Qualifications

Required Skills and Experience

• 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.
• 4+ years of relevant experience in medical device or manufacturing environment.
• Demonstrated proficiencies 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 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.
• Ability to communicate effectively both verbally and in writing Integrity: Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when Dealing with others
• Ability to work independently and handle tasks with competing priorities effectively.