Quality Engineer 2

Job Description

Primary Function of Position:

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 a professional 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 be 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:

• Quality Advocacy and Project Management
  • Develop and apply corporate level quality metrics.
  • Drive and project manage quality initiatives in one or more of these focus areas:
    • Product Quality
    • Data Quality
    • Process Quality
• New Product Development and Sustaining/Manufacturing Support
  • Handle projects of various product and subsystem types (electrical, mechanical, optical, etc).
  • Develop measurable goals for quality.
  • Ensuring that the essential performance aspects are mitigated in the product quality plans.
  • Identify critical elements of designs. Recommend design processes and methods to meet quality goals: DFX, etc.
  • Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
  • Plan and creation quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for incoming materials and finished devices.
  • 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.
  • Analyze and disposition of discrepant materials.
  • Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containments.
  • Support development and execution of process validation and verification test plans, protocols, and reports.
  • Support development and execution of manufacturing line qualification plans, protocols, and reports.
• Failure Analysis
  • Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
  • Perform 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.
• Any other Quality Engineering related function/responsibility as directed by the manager.

Qualifications

Skills, Experience, Education, & Training:

• Minimum education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
• Minimum 3+ years of working experience in Quality Engineering, minimum 2 years in medical device design or manufacturing environment.
• Able to navigate quality and compliance system with minimal oversight on personal 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 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 autonomously and make judgment based on limited information.
• Capable of initiating improvement discussion and drive 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).
• Good creative problem-solving skills.
• Good communication and documentation skills.