Senior Quality Engineer - Future Forward / NPD

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:
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.

Qualifications

Qualifications
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.