Senior Quality Engineer, Enterprise & Design Controls

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.

Primary Function of Position
This role drives enterprise level quality outcomes by leading strategic initiatives, shaping quality practices, and influencing decisions across business units. The Staff QE operates with broad autonomy and is recognized as a technical and leadership authority.

Essential Job Duties
Leads initiatives that change how quality is executed across multiples BUs or sites
Establishes standards, frameworks, or methodologies adopted beyond local teams
Serves as escalation owner for high impact product quality & compliance risks
Leadership of critical product, process investigations and audits.
Indentification, execution and advise on strategic quality projects with company wide impact.
Ownership of quality investigations for complaints and non-conformances.
Author, review, and approve QA documentation, protocols
Leadership of critical CAPAs
Serves as subject matter expert in critical audits.
Analyze and interpret advanced quality data and KPI trends.
Mentor junior and senior engineers in technical expertise.
Ensure compliance with company and regulatory standards (GMP, ISO, FDA). Provides industry expertise.
Advise cross-functional teams on quality requirements.
Indentification and ownership of continuous improvement projects.
Design Control and Risk Management Stewardship:
Planning and execution of design controls, risk management, and
design verification/validation for new products
o Advocate product design history file and ensure compliance with internal processes and external standards and
regulations.
o Understand user needs and assure they are translated to the design, while ensuring compliance 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 Accountable for overall risk management file: participate and support the development of product risk
management file, to analyze and assess the product risks associated with user, design, process and supplier.
Support design controls activities associated with new product development. Advocate and ensure the transfer of
reliable and scalable designs to manufacturing
o Review and provide feedback on design architecture, selections, requirements, and drawings from early
design.
o Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of
scalable designs into production.

Breadth of Impact and Leadership
Demonstrated impact at BU or enterprise level
Outcomes are adopted and sustained beyond the business unit
Develops other Senior QEs into future Staff level leaders
Influences senior leadership decisions through data, judgment, and presence
Acts as a role model…