Primary Function of Position The Quality Engineer II supports product development and operations from concept through commercialization and will serve as the core team member with the cross-functional product development and operations teams. The Quality engineer will provide support for design control and risk management, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. In addition, this position will play an active role to ensure that the developed products meet quality standards consistent with Intuitive's quality processes, while meeting design control and regulatory requirements. Essential Job Duties • Support manufacturing and work cross-functionally to resolve technical problems • Work closely with product development teams. • Monitor priorities and tracks progress against schedules; and communicates status to management. • Provide support in the implementation and policing of GMP, ISO and FDA requirements. • Experience and excellent understanding of pFMEAs, Root Cause, CAPAs, Non- Conformance, and Process Validation • Experience with product investigation, Identifying root cause and implementing appropriate solutions • Familiarity with data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.) • Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems • Experience with computerized systems, such as SAP, Trackwise, Agile, etc. • Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes. • Support internal and external audits, including preparation and direct interaction with auditors. • Support, designs and implements methods and/or procedures for inspecting, testing, and evaluating the precision and accuracy of products, components, sub- assemblies and/or production equipment. • Author technical documents with sufficient clarity, detail and correctness • Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset. • Other duties as assigned Qualifications Required Skills and Experience • Minimum Education: Bachelor's in engineering or STEM • Advanced degree preferred with 2+ years of working experience in Quality Engineering or related field, minimum 2 years in medical device environment. • Experience and familiarity with respect to design control and risk management from early design and development through commercialization. • Demonstrated experience with electromechanical devices. • Experience with medical standards: ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. • Able to navigate quality system with minimal oversight on individual projects. • Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges. • Able to articulate complex information to teams, including management Required Education and Training • Minimum BS in Engineering or STEM discipline is required. • Minimum 3 years of experience in a regulated industry with 1 years in Medical Device Preferred Skills and Experience • Experience with data analysis tool. i.e., Tableau, PowerBI, etc. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.