Intuitive

Healthcare

SeniorQualityEngineer

sunnyvale, california, united states FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for mid candidates.

The Brief

“Senior Quality Engineer at Intuitive. Skills: Quality functional leadership, Support product development from concept through commercialization, Expertise and guidance on design controls, risk management, process validation, and design for reliability and manufacturing, Ensure products meet quality standards, Ensure compliance with internal processes and external standards and regulations, Understand user needs and ensure they are translated into the design, Partner with engineering to define de”

What You'll Achieve.

Ensure that developed products meet quality standards consistent with Intuitive’s quality processes and all external design control and regulatory requirements; Ensure reliable and scalable designs are transferred to manufacturing; Drive product quality

Industry & Context.

Healthcare
Problems you'll solve

Ability to solve complex problems with minimal oversight; Balanced risk decision-making

Eligibility Requirements

Proof of vaccination against certain diseases including COVID-19 may be required, Subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status, Final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, 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

What They're Looking For.

Must Have

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, 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, Previous experience with running Verification & Validation Testing, 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

Nice to Have

Experience working with robotic or complex electromechanical devices, Previous experience with reliability principles, testing, reliability growth planning, and execution, Certifications such as ASQ CQE, ASQ CRE, or Six Sigma Black Belt

What You'll Do.

Contribute to the planning and execution of design controls

and design verification/validation for new products

Participate in and support the development of the product design history file

ensuring compliance with internal processes and external standards and regulations

Understand user needs and ensure they are translated into the design

while complying with usability and human factors standards and regulations

Partner with engineering to define design inputs

and traceability matrices

Contribute to the strategy and execution of risk-based design verification and validation

Participate in and support the development of the product risk management file

analyzing and assessing product risks associated with user

Ensure reliable and scalable designs are transferred to manufacturing

Review design architectures

and drawings from early design stages

Collaborate with manufacturing

and supplier engineering to facilitate the transfer of scalable designs into production

Assist in supplier selection

and performance improvement

Contribute to new product development Technical Reviews and Design Reviews

Support Regulatory Affairs with creating submissions and responding to submission questions

Support internal and external audits

including preparation and direct interaction with auditors

Support continuous improvement in design control & risk management quality processes and methodologies

How You'll Work.

Team & Collaboration

Serve as a core team member of the cross-functional product development team; Partner with engineering to define design inputs, design outputs, and traceability matrices; Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production; Ability to articulate complex information to teams, including executive management

Communication Scope

Ability to articulate complex information to teams, including executive management

Full Job 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. 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 Partici

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