Quality Engineer 3 - New Product Development (NPD)

Intuitive • Sunnyvale, CA

3d

About The Position

Primary Function of Position : As Intuitive’s da Vinci® Surgical System continues to be adopted by an increasing number of hospitals, surgeons, and patients, we are building a dedicated team to drive reliability, quality, and safety to ever-higher levels. This commitment spans products in use, in manufacturing, and in design. Join us in advancing our quality mission by bringing your hands-on experience solving complex engineering challenges, your fascination with sophisticated electro-mechanical systems, and your passion for best practices in designing, monitoring, and improving products and processes. Intuitive seeks a strong technical contributor who can: Define practical, impactful quality metrics and specifications. Identify key opportunities for product improvement. Launch and lead quality initiatives and projects. Serve as an expert consultant to resolve the most technically challenging quality issues. The ideal candidate has broad experience and deep technical expertise in at least two specialties relevant to medical robotics. You should be equally comfortable in the test lab and providing technical leadership as we develop organizational standards. You will reject unnecessary “process red tape,” instead championing efficient methods to build quality into our products. Additionally, you will coach, mentor, and influence engineering teams in best practices for quality, data analysis, protocol development, and design for reliability.

Requirements

• Bachelor’s degree in Engineering or related field (Mechanical, Electrical, Biomedical); advanced degree preferred.
• 5+ years of experience in Quality Engineering, including at least 3 years in a medical device design or manufacturing environment.
• Strong understanding of CFR 21 Part 820 and ISO 13485 requirements for process and design changes.
• Expertise in product risk management, including generating design and process FMEAs.
• Proficient in Design Controls, Change Controls, and engineering processes.
• Skilled in developing and executing qualification/validation protocols and quality assurance procedures.
• Experience leading product containment and rework activities.
• Proficient in statistical methods and tools such as Minitab to support validation and quality decisions.
• Advanced Excel skills (e.g., VLOOKUP, PivotTables, PivotCharts) for multi-source reporting, trend analysis, and data interpretation.
• Independent thinker capable of making decisions with limited information.
• Strong leadership in initiating improvement discussions and driving team success.
• Effective communicator with experience presenting to cross-functional teams and management (e.g., report writing, presentations, QRB).

Responsibilities

• Design Controls and Risk Management Support planning and execution of design controls, risk management, and design verification/validation for new products.
• Assist in developing the Design History File (DHF) and ensure compliance with internal processes and external standards/regulations.
• Assist in translating user needs into design requirements while ensuring compliance with usability and human factors standards.
• Collaborate with engineering to define design inputs, outputs, and maintain traceability matrices.
• Contribute to risk based design verification and validation activities.
• Support development of the product Risk Management File, analyzing risks related to user, design, process, and suppliers.
• Review design architectures, requirements, and drawings during early development stages.
• Partner with manufacturing, purchasing, test engineering, and supplier engineering to enable smooth transfer of designs into production.
• Assist in supplier selection, qualification, certification, and performance improvement initiatives.
• Participate in Technical Reviews and Design Reviews for new product development.
• Collaborate with Regulatory Affairs to prepare submissions and respond to regulatory inquiries.
• Support internal and external audits, including preparation and direct interaction with auditors.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level