Quality Engineer 3 - New Product Development (NPD)

Location: Sunnyvale, CA, us

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

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.

Essential Job Duties

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.

Design Transfer and Manufacturing Readiness

•  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.

Regulatory and Compliance Support

•  Collaborate with Regulatory Affairs to prepare submissions and respond to regulatory inquiries.
•  Support internal and external audits, including preparation and direct interaction with auditors.

Qualifications

Required Skills and Experience 

• 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).

Required Education and Training 

• Bachelor’s degree in Engineering or related field (Mechanical, Electrical, Biomedical); advanced degree preferred.

Working Conditions

• none

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.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

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 (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

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.