Senior Quality Engineer - Future Forward / NPD

Requirements

• Skills, Experience, Education, & Training:
•  Requires a minimum of 8 years of related experience with a University Degree (in
• Electrical Engineering, Mechanical Engineering, Computer Science, software engineering,
• biomedical engineering), or 6 years of relevant experience and an Advanced Degree.
•  Strong proficiency in FDA Design Controls and international standards, including ISO
• 13485, ISO 14971, and IEC 60601/62304. Previous experience with risk-based V&V,
• process validation, and limit/challenge testing are required.
•  Experience working with robotic or complex electromechanical devices is preferred.
•  Previous experience with reliability principles, testing, reliability growth planning, and
• execution is preferred
•  Previous experience with running Verification & Validation Testing is required.
•  Ability to navigate quality systems with minimal oversight on individual projects.
•  Balanced risk decision-making to drive product quality, gain consensus, and work through
• technical challenges.
•  Ability to solve complex problems with minimal oversight. Ability to articulate complex
• information to teams, including executive management.
•  Certifications such as ASQ CQE, ASQ CRE, or Six Sigma Black Belt are preferred.
• 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.
• Mandatory Notices
• U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
• Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to

Additional Information

Primary Function of Position: Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for a strong quality functional leader to support the projects associated with the development of next generation products. The Quality Engineer supports product development from concept through commercialization and serves as a core team member of the cross-functional product development team. This role provides expertise and guidance on design controls, risk management, process validation, and design for reliability and manufacturing. Additionally, the position ensures that developed products meet quality standards consistent with Intuitive' s quality processes and all external design control and regulatory requirements. Roles & Responsibilities:  Design Controls and Risk Management: o Contribute to the planning and execution of design controls, risk management, and design verification/validation for new products. o Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations. o Understand user needs and ensure they are translated into the design, while complying with usability and human factors standards and regulations. o Partner with engineering to define design inputs, design outputs, and traceability matrices. o Contribute to the strategy and execution of risk-based design verification and validation. o Participate in and support the development of the product risk management file, analyzing and assessing product risks associated with user, design, process, and supplier.  Design Transfer: o Ensure reliable and scalable designs are transferred to manufacturing. o Review design architectures, selections, requirements, and drawings from early design stages. o Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production. o Assist in supplier selection, qualification, certification, and performance improvement. o Contribute to new product development Technical Reviews and Design Reviews.  Regulatory Support: o Support Regulatory Affairs with creating submissions and responding to submission questions. o Support internal and external audits, including preparation and direct interaction with auditors.  Process Improvement & Cross-Functional Collaboration o Support continuous improvement in design control & risk management quality processes and methodologies.

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