Primary Function of Position: 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 optics, and is equally at home in the test lab, on the manufacturing shopfloor 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: New Product Development and Sustaining/Manufacturing Support Handle projects of various product and subsystem/component types (electrical, mechanical, optical, etc). Develop measurable goals for quality and lead Quality Table meetings. 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 create quality standards, quality control, and quality assurance procedures, 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 material. 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. Support and drive MVP/R projects. Failure Analysis Provide quality expertise to the quality engineering support team to analyze the product failure. Perform deep 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. Quality Advocacy and Project Management Create, process and review various types of Quality Notifications and Change Orders. Develop and apply corporate level quality metrics. Lead quality meetings e.g. QDR (Quality Data Review). Lead and project manage quality initiatives in one or more of these focus areas: Product Quality, Data Quality, Process Quality. Perform mock audits and Gemba walks to ensure compliance with ISI QMS. Participate in audits (front/back room). Develop, lead and communicate intercompany Quality Engineering projects.
Required Knowledge, Skills, and Experience: Bachelor’s degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred. 5+ years of working experience in Quality Engineering or Process Engineering with quality improvement projects participation, 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 Design Controls, Change Controls, Product, and Engineering Processes. Proficient with generate and execute Qualification and Validation protocols and Quality Assurance Procedures. Experienced in leading product containment and rework activities. Proficient in SPC & Six Sigma methodology and tools. Experienced in typical Excel data analysis operations. 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). Excellent creative problem-solvin